Tsay et al. (2008): Effects of Reflexotherapy on Acute Postoperative Pain and Anxiety Among Patients With Digestive Cancer.

Reference ↗
Title	Effects of Reflexotherapy on Acute Postoperative Pain and Anxiety Among Patients With Digestive Cancer.
Topic	Reflexology
Author	Tsay SL, Chen HL, Chen SC, Lin HR, Lin KC
Year	2008
Journal	Cancer Nursing
DOI	https://doi.org/10.1097/01.NCC.0000305694.74754.7b

Brief summary

62 cancer patients were randomly assigned to one of two arms. One arm received one session of reflexotherapy in addition to conventional treatment immediately after the operation for four days, the other group did not. The patients were interviewed with regard to pain and anxiety using established questionnaires/instruments. The arms were comparable in all respects beforehand. Over the study period, there was a difference between the arms in terms of pain and anxiety, with the patients who had received reflex therapy making more positive statements. This difference was not only statistically demonstrable on an instrument, but also significant for the patients. In addition, the request for anesthetics was lower in the reflex therapy arm on the fifth and sixth day of the study (39.59 mg Demerol). It was not evaluated whether the patients also received different amounts of analgesics via patient-controlled analgesia beforehand. As the control group did not receive a comparable placebo, the positive effects cannot be explicitly attributed to the reflexology massage. The results could just as well have been due to the additional attention, touch or the effect of a simple foot massage.

62 Krebspatienten wurden zufällig in eine von zwei Gruppen eingeteilt. Die eine Gruppe hat zusätzlich zur konventionellen Behandlung direkt nach der OP vier Tage lang jeweils eine Sitzung Reflextherapie erhalten, die andere Gruppe nicht. Die Patienten wurden hinsichtlich Schmerzen und Angst mit etablierten Fragebögen/ Instrumenten befragt. Die Gruppen waren in allen Belangen vorab vergleichbar. Über die Studienzeit hinweg zeigte sich ein Gruppenunterschied hinsichtlich der Angaben von Schmerzen und Angst, wobei die Patienten, die Reflextherapie erhalten hatten, positivere Angaben machten. Auf einem Instrument war dieser Unterschied nicht nur statistisch nachweisbar, sondern für die Patienten auch bedeutsam. Zudem war in der Reflextherapiegruppe die Anfrage nach Betäubungsmitteln am fünften und sechsten Tag der Studie geringer (39,59 mg Demerol). Es wurde nicht ausgewertet, ob die Patienten davor auch unterschiedliche Mengen an Schmerzmitteln über die patientengesteuerte Analgesie erhielten. Da die Kontrollgruppe kein vergleichbares Placebo erhalten hat, lassen sich die positiven Effekte nicht explizit der Reflexzonen-Massage zuschreiben. Die Ergebnisse können genauso gut durch die zusätzliche Aufmerksamkeit, Berührung oder den Effekt einer einfachen Fußmassage zustande gekommen sein.

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	Prospective
Monocentric / Multicentric Monocentric: conducted in one center/ hospital; </br>Multicentric: conducted in multiple centers/ hospitals	Monocentric
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	Double
Is randomized	Yes
Cross-over Participants alternate between different treatment groups or conditions over a specified period, allowing each participant to serve as their own control	No
Number of arms	2

Study characteristics

Inclusion criteria	?
Exclusion criteria	?
N randomized	-999
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.	?
Specifications on analyses	?
Countries of data collection	?
LoE Level of evidence	?
Outcome timeline Data collection times	?

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.	?
Types of cancer "Other Cancers" means that only a subpopulation was specified, but further unspecified cancer types were included	?
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	?
Specifications on cancer stages	?
Comorbidities	?
Current cancer therapies	?
Specifications on cancer therapies	?
Previous cancer therapies	?
Gender	?
Gender specifications	?
Age groups
Age groups specification	?

Arms

Arm type Active control: group receives active treatment; </br>Passive control: for example treatment as usual, waiting control, no treatment	Intervention
Number of participants (arm) N randomized	31
Drop-out Number of participants who left the study for any reason or did not provide information on every data collection date	N=0
Drop-out reasons	NA
Intervention	Reflexotherapy
Dosage and regime	The foot reflexology was initiated during the evening on postoperative day 2 while patients are on PCA and between 1 and 3 hours after a dose of pain medication, day 3 after surgery and day 4 after surgery, duration: 20 min each)
One-time application	No
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.	3
Side effects / Interactions	NI

Arm type Active control: group receives active treatment; </br>Passive control: for example treatment as usual, waiting control, no treatment	Passive control
Number of participants (arm) N randomized	31
Drop-out Number of participants who left the study for any reason or did not provide information on every data collection date	N=1
Drop-out reasons	Postoperative complications
Intervention	Surgery
Dosage and regime	NA
One-time application	No
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.	1
Side effects / Interactions	NI

Outcomes

Pain

Outcome type As specificed by the authors	Primary
Outcome specification	Baseline; T1-T3 (Day 2 post surgery - Day 4 post surgery, follow-up) Value; coefficient of the time x group interaction effect βI (standard error),p-value
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".	On average (across all time points), there are sig. lower (better) values in intervention than in passive control arm (βG=-21.22 (4.93); p<0.001). In addition, there is a sig. different development in the two arms, in the sense that the values in intervention tend to remain the same, whereas they tend to increase in passive control arm (βI= -2.41 (1.38); p=0.0107).
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
Outcome specification	Baseline, Follow-up
Type of measurement	SF-MPQ (Short-Form McGill Pain Questionnaire)
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".	On average (across all time points) there are no sig. differences between the two arms (βG=-0.63 (1.23); p=0.61). However, there is a decrease in symptoms in both arms, which is sig. stronger in intervention arm over time (βI= -3.17 (1.41); p=0.02).
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	?

Anxiety

Outcome type As specificed by the authors	Primary
Outcome specification	Baseline, Follow-up
Type of measurement	HADS (Hospital Anxiety and Depression 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".	On average (across all time points) there are no sig. differences between the two arms (βG=0.31 (0.98); p=0.753). But in both arms there is a decrease in symptoms, which is sig. stronger in intervention arm over time (βI= -1.12 (0.49); p=0.231).
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	?

Additional medication

Outcome type As specificed by the authors	Primary
Outcome specification	Postoperative opiate consumption: Meperidin, Follow-up
Type of measurement	Observation
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".	NA
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".	Sig. lower consumption in intervention than arm passive control (mean diff.= 39.59 mg Demerol; p= 0.015)

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	?

Funding and Conflicts of Interest

Funding	?
Conflicts of Interest	?

Further points for assessing the study

Sample

Power analysis performed	?
- Sample size corresponds to power analysis	?
- Reasons for insufficient sample size based on power analysis	?
If no power analysis performed: at least moderate sample size (n >= 30 per arm)	?
Ethnicity mentioned	?

Alternative Explanation

Other explanations for an effect besides the investigated intervention	?
- Possibility of attention effects	?
- Possibility of placebo effects	?
- Other reasons	?

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	?
Correction for multiple testing	?
Measurement of compliance	?
Consistent reporting in numbers (figures, flowchart, abstract, results)	?
Comprehensive and coherent reporting	?
Cross-over	?
- Sufficient washout period	?
- Tested for carry-over effects	?
- Tested for sequence effects	?

Interpretation of results

Effect sizes reported (clinical vs. statistical significance)	?
Side effects systematically recorded	?
Side effects considered in result interpretation	?
Ethics votum	?

Additional Notes

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