Clinical trial NCT06972199: Reflexology Massage and Hot Water Foot Bath for Pain and GI Recovery After Colorectal Surgery
Official title: The Effect of Reflexology Massage and Hot Water Foot Bath on Pain and Gastrointestinal Functions After Colorectal Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Surgery
Reflexology
Traditional Chinese Medication (TCM)
Nursing
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2025-05-14
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was planned to examine the effect of non-invasive treatment methods that can be applied to alleviate complications involving gastrointestinal system functions such as pain, nausea, vomiting, and absence of gas/faecal output after colorectal (colon and rectum) cancer surgery. The two main intervention methods of the study were reflexology massage and hot water foot bath. The effects of these methods on reducing postoperative pain and improving gastrointestinal functions will be investigated. The study was planned as a randomised controlled experimental study to determine the effects of reflexology massage and hot water foot bath on postoperative pain and gastrointestinal functions in colorectal cancer patients undergoing laparoscopic surgery. It is thought that the study will provide evidence for determining the appropriate method to reduce pain and improve gastrointestinal functions in patients undergoing colorectal cancer surgery. The population of the study will consist of colorectal cancer patients who will undergo laparoscopic surgical intervention who are admitted to the General Surgery Clinic of SBU Istanbul Ümraniye Training and Research Hospital.

Based on the percentage measurement values of the methods to be studied in the literature review, G-POWER programme was used for sample calculation with an effect size of 0.4 (Cohen), 95% power and 0.05% margin of error. Cohen\&#39;s standard effect size was taken as the basis for the effect size. The calculated value is the total value for 3 groups and the total sample size for 3 groups was found as n=102. The number of samples per group was determined as (n)=34. In order to prevent bias in the study, patients who meet the study criteria will be distributed to the experimental and control groups by computerised randomisation programme. Data will be collected by using the Patient Information Form consisting of two parts, Rhodes Nausea, Vomiting and Retching Index and Numerical Proportioning Scale (NRS) developed by the researcher in line with the literature. The data obtained will be evaluated with appropriate statistical methods in the licensed SPSS 21.0 package programme.

Detailed description: This randomized controlled trial aims to evaluate the effectiveness of two non-pharmacological interventions-reflexology massage and hot water foot bath-on postoperative pain and gastrointestinal function in patients undergoing laparoscopic colorectal cancer surgery. The interventions will be applied in three groups: reflexology massage, hot water foot bath, and control group. Participants will be randomly assigned to groups using a computerized randomization method. Pain will be assessed using the Numerical Rating Scale (NRS), and gastrointestinal function will be evaluated through time to first gas and feces passage, as well as bowel sounds. Additionally, the Rhodes Index of Nausea, Vomiting, and Retching (RINVR) will be used to monitor symptoms related to postoperative nausea and vomiting. Data will also be collected using a researcher-developed Data Collection Form consisting of:

* Sociodemographic characteristics
* Medical and surgical history
* Postoperative vital signs (blood pressure, pulse, temperature, etc.)
* Gastrointestinal follow-up (bowel sounds per minute, time of first gas and feces output) This form was developed based on current literature and clinical practice guidelines and piloted prior to study launch. All data will be analyzed using SPSS 21.0.

The sample size was calculated using G\*Power based on an effect size of 0.4 (Cohen), 95% power, and a 0.05 margin of error, resulting in 102 total participants (n=34 per group).

Ethical approval was obtained from the Non-Interventional Clinical Research Ethics Committee of Fenerbahçe University. The study is being conducted at the General Surgery Clinic of SBÜ Ümraniye Training and Research Hospital.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older,
* Planning laparoscopic surgery for a malignant tumour in the large intestine,
* The same method was used for preoperative bowel and GI tract preparation,
* Postoperative Numerical Proportioning Scale (NRS) score of 3 and above,
* Verbal and written acceptance to participate in the research.

Exclusion Criteria:

* The patient has a temporary or permanent stoma,
* Having a history of reflexology application before,
* Open wound, infection, circulatory disorder, lesion, etc. in the areas where reflexology massage or hot water foot bath will be applied,
* Patient-controlled analgesia in the early postoperative period
* Having any problem that prevents verbal communication.

Primary outcomes:
measure: Pain level
timeFrame: Within 24 hours postoperatively
measure: Gas release time
timeFrame: Within 24 hours postoperatively
Secondary outcomes:
measure: Neusea
timeFrame: Within 24 hours postoperatively
measure: Number of vomiting
timeFrame: Within 24 hours postoperatively
Other outcomes:
measure: Time to First Flatus
timeFrame: Within 48 hours postoperatively
measure: Time to First Defecation
timeFrame: Within 72 hours postoperatively
measure: Time to Tolerate Oral Diet
timeFrame: within 24 hours postoperatively
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpaşa
city: Istanbul
country: Turkey
facility: University of Health Sciences, Umraniye Training and Research Hospital
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Cansu Mert, Master
role: PRINCIPAL_INVESTIGATOR
References: