Reflexology Massage and Hot Water Foot Bath for Pain and GI Recovery After Colorectal Surgery

NCT06972199 | Recruiting

• 1 other identifier: 18.2024fbu
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 2

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\'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.

Conditions

Colorectal Surgery; Reflexology; Traditional Chinese Medication (TCM); Nursing

Outcome Measures

Primary Outcomes (2)

• Pain level

  Postoperative pain levels of the participants will be measured with the Numerical Rating Scale (NRS), which ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain.

  Within 24 hours postoperatively

• Gas release time

  Time to first gas release of participants in the postoperative period after surgery

  Within 24 hours postoperatively

Secondary Outcomes (2)

• Neusea

  Within 24 hours postoperatively

• Number of vomiting

  Within 24 hours postoperatively

Other Outcomes (3)

• Time to First Flatus

  Within 48 hours postoperatively

• Time to First Defecation

  Within 72 hours postoperatively

• Time to Tolerate Oral Diet

  within 24 hours postoperatively

Study Arms (3)

Reflexology

EXPERIMENTAL

Reflexology application

Behavioral: Reflexology

Hot water foot bath

EXPERIMENTAL

Hot water foot bath application

Behavioral: Hot water foot bath

Control

NO INTERVENTION

There will be no intervention

Interventions

Reflexology BEHAVIORAL

Reflexology application

Reflexology

Hot water foot bath BEHAVIORAL

Hot water foot bath application

Hot water foot bath

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (2)

Istanbul University-Cerrahpaşa

Istanbul, Istanbul, 34320, Turkey (Türkiye)

NOT YET RECRUITING

University of Health Sciences, Umraniye Training and Research Hospital

Istanbul, 34764, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Musculoskeletal Manipulations

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Cansu Mert, Master

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cansu Mert, Master

CONTACT

536 595 4172; cannsumert@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral Student

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 14, 2025
• Study Start: October 30, 2024
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 14, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)