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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIstanbul University - Cerrahpasa

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Reflexology

    Behavioral

    Reflexology application

  • Hot water foot bath

    Behavioral

    Hot water foot bath application

Treatment groups

102 Participants
are divided into 3 treatment groups
Group A: ReflexologyExperimental treatment 1 intervention
Group B: Hot water foot bathExperimental treatment 1 intervention
Group C: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Within 24 hours postoperatively
2

Gas release time

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

Time frame
Within 24 hours postoperatively

Secondary outcomes

1

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.

Time frame
Within 24 hours postoperatively
2

Number of vomiting

The number of vomits occurring in the participants in the postoperative period will be recorded.

Time frame
Within 24 hours postoperatively

Other outcomes

1

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 frame
Within 48 hours postoperatively
2

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 frame
Within 72 hours postoperatively
3

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.

Time frame
within 24 hours postoperatively

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