About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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,
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Reflexology
BehavioralReflexology application
Hot water foot bath
BehavioralHot water foot bath application
Treatment groups
Trial outcomes
Primary outcomes
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.
Gas release time
Time to first gas release of participants in the postoperative period after surgery
Secondary outcomes
Neusea
In the postoperative period, nausea and vomiting will be evaluated with the Rhodes Nausea, Vomiting and Retching Index (RNVRI), which has a total score range from 0 to 32. Higher scores indicate more severe symptoms.
Number of vomiting
The number of vomits occurring in the participants in the postoperative period will be recorded.
Other outcomes
Time to First Flatus
The time (in hours) from the end of surgery until the first passage of flatus, as recorded by the participant and verified by nursing staff. This value will be recorded in the Postoperative Bowel Function Monitoring Form.
Time to First Defecation
The time (in hours) from the end of surgery until the first defecation (bowel movement). Patients will self-report and nurses will document the exact time. Recorded in the postoperative bowel function table.
Time to Tolerate Oral Diet
The time (in hours) from the end of surgery until the patient tolerates the first full oral diet without nausea or vomiting. Evaluated via dietary intake and nurse monitoring records.
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