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| {{Reference | | {{Reference |
| |Reference=Publication: The Effects of Foot Reflexology on Anxiety and Pain in Patients With Breast and Lung Cancer. | | |Reference=The Effects of Foot Reflexology on Anxiety and Pain in Patients With Breast and Lung Cancer. |
| }} | | }} |
| {{Study Note}} | | {{Study Note}} |
Revision as of 08:11, 17 September 2024
Study Note
Brief summary
In this study, breast and bronchial cancer patients were randomly divided into two arms. One arm received one session of reflex therapy on the first day and no special intervention for the following three days. The other arm received no special intervention for the first three days and then reflex therapy on the fourth day. In both arms, the patient was asked about anxiety and pain on the first and fourth day. The statistical analysis shows such serious errors that the results of this study cannot be interpreted.
In dieser Studie wurden Brust- und Bronchialkrebspatienten zufällig in zwei Gruppen aufgeteilt. Die eine Gruppe hat am ersten Tag zuerst eine Sitzung Reflextherapie erhalten und die darauffolgenden drei Tage keine besondere Intervention. Die andere Gruppe hat die ersten drei Tage keine besondere Intervention bekommen und dann am vierten Tag die Reflextherapie. In beiden Gruppen wurden die Patientin jeweils am ersten und am vierten Tag nach Angst und Schmerzen befragt. Die statistische Auswertung weist so gravierende Fehler auf, so dass die Ergebnisse dieser Studie nicht interpretierbar sind.
Study Design
| Prospective / Retrospective Prospective: forward-looking, examples include clinical trials, cohort studies, and long-term observational studies;</br>Retrospective: backward-looking, relying on existing data, examples include case-control studies and retrospective cohort studies
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Prospective
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| Monocentric / Multicentric Monocentric: conducted in one center/ hospital; </br>Multicentric: conducted in multiple centers/ hospitals
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Monocentric
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| Blinding No: Open, all parties are aware of group assignments;</br>Single: one party is unaware of group assignments (generally participants);</br>Double: two parties are unaware of group assignments (generally the participants and the researchers); </br>Triple: concealing group assignment from additional parties
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No
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| Is randomized
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Yes
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| Cross-over Participants alternate between different treatment groups or conditions over a specified period, allowing each participant to serve as their own control
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Yes
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| Number of arms
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2
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Study characteristics
| Inclusion criteria
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?
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| Exclusion criteria
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?
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| N randomized
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-999
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| Analysis PP: Per Protocol analysis, i.e. only participants included who adhered to the study protocol.</br>ITT: Intention-to-treat analysis, i.e. all randomized participants included regardless of any drop-outs or changes in assignment.</br>mITT: modified Intention-to-treat analysis can refer to analyses in which participants with missing outcome data are excluded or it can refer to analyses in which only participants who received at least one treatment dose are included. In this case, participants dropped out of the study prematurely for reasons unrelated to the treatment.
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?
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| Specifications on analyses
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?
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| Countries of data collection
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?
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| LoE Level of evidence
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?
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| Outcome timeline Data collection times
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?
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Characteristics of participants
| Setting Refers to cancer therapy setting.</br>- Curative therapy: aims to completely eradicate a disease and achieve a full recovery; </br>- Neo-adjuvant therapy: form of curative therapy, given before the primary treatment for cancer (usually surgery); </br>- Adjuvant therapy: form of curative therapy, given after the primary treatment for cancer (usually surgery); </br>- Palliative therapy: focuses on providing relief from symptoms and improving the quality of life for patients, without necessarily targeting the underlying disease; </br>- Active surveillance: involves close monitoring of disease progression without any intervention (typically used for prostate cancer);</br>- No therapy setting: Patients who completed therapy/are currently not in cancer treatment, cancer survivors.
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?
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| Types of cancer "Other Cancers" means that only a subpopulation was specified, but further unspecified cancer types were included
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?
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| Cancer stages Early Stage: generally refers to cancer that is localized to the area where it started, mostly stages I and II;</br>Advanced Stage: cancer that has spread beyond its original site, mostly stages III and IV, with stage IV indicating distant metastasis
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?
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| Specifications on cancer stages
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?
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| Comorbidities
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?
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| Current cancer therapies
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?
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| Specifications on cancer therapies
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?
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| Previous cancer therapies
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?
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| Gender
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?
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| Gender specifications
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?
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| Age groups
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| Age groups specification
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?
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Arms
| Arm type Active control: group receives active treatment; </br>Passive control: for example treatment as usual, waiting control, no treatment
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Intervention, Placebo
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| Number of participants (arm) N randomized
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-999
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| Drop-out Number of participants who left the study for any reason or did not provide information on every data collection date
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NI
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| Drop-out reasons
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NI
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| Intervention
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Reflexotherapy
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| Dosage and regime
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Received reflexology first and then served as their own control.
(1x 30 min), at least 48 h break, passive control/no intervention (1x 30 min)
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| One-time application
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No
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| Duration in days For long-term interventions, the number of days is an estimation.</br>A value of -999 indicates that the exact duration cannot be extracted from the study due to ambiguous or incomplete information. See Outcome timeline or Dosage and regime for further information.
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1
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| Side effects / Interactions
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NI
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| Arm type Active control: group receives active treatment; </br>Passive control: for example treatment as usual, waiting control, no treatment
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Intervention, Placebo
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| Number of participants (arm) N randomized
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-999
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| Drop-out Number of participants who left the study for any reason or did not provide information on every data collection date
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NI
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| Drop-out reasons
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NI
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| Intervention
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Reflexotherapy
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| Dosage and regime
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Patients served as their own control first and then received reflexology;
passive control/no intervention (1x 30 min), at least 48 h break, reflex therapy (1x 30 min)
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| One-time application
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No
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| Duration in days For long-term interventions, the number of days is an estimation.</br>A value of -999 indicates that the exact duration cannot be extracted from the study due to ambiguous or incomplete information. See Outcome timeline or Dosage and regime for further information.
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1
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| Side effects / Interactions
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NI
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Outcomes
Anxiety
| Outcome type As specificed by the authors
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Primary
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| Outcome specification
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NA
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| Type of measurement
|
VAS (Visual Analogue Scale)
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| Results during intervention - Results during intervention means that the time of data collection is during or shortly after the period of the intervention (e.g. on the last day or a few days after). The results therefore still relate to the direct effects of the intervention.</br>- Results after intervention means there is a longer break between the time of data collection and the end of the intervention, e.g. more than a week. The results relate more to long-term effects.</br>- If a categorization in Results during vs. after intervention is not possible (e.g. survival data), the results are summarized under Results after intervention under the headline "Overall".
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Patients had significantly better scores after the intervention than after the control condition (mean diff.= -21.83; p<0.000).
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| Results after intervention - Results during intervention means that the time of data collection is during or shortly after the period of the intervention (e.g. on the last day or a few days after). The results therefore still relate to the direct effects of the intervention.</br>- Results after intervention means there is a longer break between the time of data collection and the end of the intervention, e.g. more than a week. The results relate more to long-term effects.</br>- If a categorization in Results during vs. after intervention is not possible (e.g. survival data), the results are summarized under Results after intervention under the headline "Overall".
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NA
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| Risk of Bias Assessment: Cochrane RoB tool 2.0
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| Bias arising from the randomization process
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?
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| Bias due to deviation from intended intervention (assignment to intervention)
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?
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| Bias due to deviation from intended intervention (adhering to intervention)
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NA
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| Bias due to missing outcome data
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?
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| Bias in measurement of the outcome
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?
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| Bias in selection of the reported result
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?
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| Other sources of bias
|
?
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| Overall RoB judgment
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?
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Pain
| Outcome type As specificed by the authors
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Primary
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| Outcome specification
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NA
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| Type of measurement
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SF-MPQ (Short-Form McGill Pain Questionnaire)
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| Results during intervention - Results during intervention means that the time of data collection is during or shortly after the period of the intervention (e.g. on the last day or a few days after). The results therefore still relate to the direct effects of the intervention.</br>- Results after intervention means there is a longer break between the time of data collection and the end of the intervention, e.g. more than a week. The results relate more to long-term effects.</br>- If a categorization in Results during vs. after intervention is not possible (e.g. survival data), the results are summarized under Results after intervention under the headline "Overall".
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13 patients with breast cancer (11 reporting pain) experienced a significant decrease in pain following foot reflexology as measured by the descriptive words of the SF-MPQ (see Table 3). Because only two patients with lung cancer reported pain, results from this group of subjects could not be calculated. The differences in pain between the groups as measured by the PPI and VAS were not significant (mean diff= -0.41; p<0.05).
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| Results after intervention - Results during intervention means that the time of data collection is during or shortly after the period of the intervention (e.g. on the last day or a few days after). The results therefore still relate to the direct effects of the intervention.</br>- Results after intervention means there is a longer break between the time of data collection and the end of the intervention, e.g. more than a week. The results relate more to long-term effects.</br>- If a categorization in Results during vs. after intervention is not possible (e.g. survival data), the results are summarized under Results after intervention under the headline "Overall".
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NA
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| Risk of Bias Assessment: Cochrane RoB tool 2.0
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| Bias arising from the randomization process
|
?
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| Bias due to deviation from intended intervention (assignment to intervention)
|
?
|
| Bias due to deviation from intended intervention (adhering to intervention)
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NA
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| Bias due to missing outcome data
|
?
|
| Bias in measurement of the outcome
|
?
|
| Bias in selection of the reported result
|
?
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| Other sources of bias
|
?
|
| Overall RoB judgment
|
?
|
Pain
| Outcome type As specificed by the authors
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Primary
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| Outcome specification
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PPI-Scale
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| Type of measurement
|
SF-MPQ (Short-Form McGill Pain Questionnaire)
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| Results during intervention - Results during intervention means that the time of data collection is during or shortly after the period of the intervention (e.g. on the last day or a few days after). The results therefore still relate to the direct effects of the intervention.</br>- Results after intervention means there is a longer break between the time of data collection and the end of the intervention, e.g. more than a week. The results relate more to long-term effects.</br>- If a categorization in Results during vs. after intervention is not possible (e.g. survival data), the results are summarized under Results after intervention under the headline "Overall".
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Only the breast cancer patients were evaluated: no sig. difference between intervention and control.
|
| Results after intervention - Results during intervention means that the time of data collection is during or shortly after the period of the intervention (e.g. on the last day or a few days after). The results therefore still relate to the direct effects of the intervention.</br>- Results after intervention means there is a longer break between the time of data collection and the end of the intervention, e.g. more than a week. The results relate more to long-term effects.</br>- If a categorization in Results during vs. after intervention is not possible (e.g. survival data), the results are summarized under Results after intervention under the headline "Overall".
|
NA
|
| Risk of Bias Assessment: Cochrane RoB tool 2.0
|
| Bias arising from the randomization process
|
?
|
| Bias due to deviation from intended intervention (assignment to intervention)
|
?
|
| Bias due to deviation from intended intervention (adhering to intervention)
|
NA
|
| Bias due to missing outcome data
|
?
|
| Bias in measurement of the outcome
|
?
|
| Bias in selection of the reported result
|
?
|
| Other sources of bias
|
?
|
| Overall RoB judgment
|
?
|
Pain
| Outcome type As specificed by the authors
|
Primary
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| Outcome specification
|
NA
|
| Type of measurement
|
VAS (Visual Analogue Scale)
|
| Results during intervention - Results during intervention means that the time of data collection is during or shortly after the period of the intervention (e.g. on the last day or a few days after). The results therefore still relate to the direct effects of the intervention.</br>- Results after intervention means there is a longer break between the time of data collection and the end of the intervention, e.g. more than a week. The results relate more to long-term effects.</br>- If a categorization in Results during vs. after intervention is not possible (e.g. survival data), the results are summarized under Results after intervention under the headline "Overall".
|
Only the breast cancer patients were evaluated: no sig. difference between intervention and control.
|
| Results after intervention - Results during intervention means that the time of data collection is during or shortly after the period of the intervention (e.g. on the last day or a few days after). The results therefore still relate to the direct effects of the intervention.</br>- Results after intervention means there is a longer break between the time of data collection and the end of the intervention, e.g. more than a week. The results relate more to long-term effects.</br>- If a categorization in Results during vs. after intervention is not possible (e.g. survival data), the results are summarized under Results after intervention under the headline "Overall".
|
NA
|
| Risk of Bias Assessment: Cochrane RoB tool 2.0
|
| Bias arising from the randomization process
|
?
|
| Bias due to deviation from intended intervention (assignment to intervention)
|
?
|
| Bias due to deviation from intended intervention (adhering to intervention)
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NA
|
| Bias due to missing outcome data
|
?
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| Bias in measurement of the outcome
|
?
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| Bias in selection of the reported result
|
?
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| Other sources of bias
|
?
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| Overall RoB judgment
|
?
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Funding and Conflicts of Interest
| Funding
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?
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| Conflicts of Interest
|
?
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Further points for assessing the study
Sample
| Power analysis performed
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?
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| - Sample size corresponds to power analysis
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?
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| - Reasons for insufficient sample size based on power analysis
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?
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| If no power analysis performed: at least moderate sample size (n >= 30 per arm)
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?
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| Ethnicity mentioned
|
?
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Alternative Explanation
| Other explanations for an effect besides the investigated intervention
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?
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| - Possibility of attention effects
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?
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| - Possibility of placebo effects
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?
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| - Other reasons
|
?
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Statistics
| Correct use of parametric and non-parametric tests Testing for normal distribution only necessary if parametric tests are used, NI: use of parametric tests without report of normal distribution testing
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?
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| Correction for multiple testing
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?
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| Measurement of compliance
|
?
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| Consistent reporting in numbers (figures, flowchart, abstract, results)
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?
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| Comprehensive and coherent reporting
|
?
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| Cross-over
|
?
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| - Sufficient washout period
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?
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| - Tested for carry-over effects
|
?
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| - Tested for sequence effects
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?
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Interpretation of results
| Effect sizes reported (clinical vs. statistical significance)
|
?
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| Side effects systematically recorded
|
?
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| Side effects considered in result interpretation
|
?
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| Ethics votum
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?
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Additional Notes
?
