The Effect of Foot Reflexology on Patients Undergoing Appendectomy Surgery

May 6, 2024 updated by: Buket Köse Çetinalp, Bartın Unıversity

The Effect of Foot Reflexology on Pain Intensity, Sleep Quality and Bowel Functions in Patients Undergoing Appendectomy Surgery

Pain is an unpleasant experience that can negatively affect all aspects of the patients life and lead to a decrease in quality of life. Pain can also be encountered as a reason for a surgical intervention. For this reason, it has become one of the most common problems experienced by patients in the postoperative period. Pain management is a universal requirement in health care and is of great importance for patients. If the pain is not managed well in the postoperative period, it may cause some complications in the patient. If pain is controlled, early discharge of the patient, lower healthcare costs and increased patient satisfaction are achieved. In terms of providing effective pain control, it is provided by nurses, who are health professionals, to spend more time with the patient, to lead the patient in pain management and to analyze the results. The aim of the thesis study is to evaluate the effect of foot reflexology on pain intensity, sleep quality and bowel functions in patients who have undergone appendectomy surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Optimal management of postoperative pain is associated with reduced morbidity and faster recovery times, as well as improved physical function and quality of life. Despite efforts to minimize postoperative pain, 61% of outpatients still experience moderate/extreme pain upon discharge. Pain management is an important aspect of patient care, and nurses play an important role in providing pain assessment and treatment in the acute care setting. The use of non-pharmacological pain relief techniques has been found to be effective with fewer side effects and complications. Reflexology, one of the types of complementary and alternative medicine, has begun to be used as a nursing intervention along with modern medicine as a non-pharmacological method. When the investigators look at the past years; The effects of foot reflexology on pain intensity, nausea, anxiety, delirium, and hemodynamic parameters were investigated. The studies conducted include cancer patients, burn patients, intensive care patients and dialysis patients. However, in previous studies, no study was found investigating the effect of foot reflexology on sleep quality and bowel functions in patients undergoing surgical intervention. This study is thought to be the first to evaluate the effect of foot reflexology on sleep quality and bowel functions in surgical patients. In this respect, it is a study that will contribute to the literature.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Centrical
      • Bartın, Centrical, Turkey, 74100
        • Bartın University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • • 18 years and over,

    • Having undergone appendectomy surgery,
    • No complications such as bleeding, nausea or vomiting after appendectomy surgery,
    • Not using patient-controlled analgesia for postoperative pain control,
    • Pain score ≥4 according to the Visual Analog Scale,
    • No hypertension problems,
    • Able to speak and understand Turkish
    • No visual or auditory problems,
    • No diagnosed psychiatric problems,
    • No diagnosed bowel problems,
    • Do not have infectious skin diseases on their feet (such as zoster, fungus, warts, eczema),
    • Patients who do not have deep vein thrombosis, tombophlebitis, any fracture, neuropathy, osteomyelitis, osteoporosis, or ligament injury in their feet or legs,
    • Volunteer patients will be included.

Exclusion Criteria:

  • • Complications developed after appendectomy surgery,

    • Pain score <4 according to the Visual Analog Scale,
    • Those with hypertension problems,
    • Unable to communicate,
    • Having visual or auditory problems,
    • Having a diagnosed psychiatric problem,
    • Having a diagnosed bowel problem,
    • Those with infectious skin diseases on their feet (such as zoster, fungus, warts, eczema),
    • Patients with deep vein thrombosis, tombophlebitis, any fracture, neuropathy, osteomyelitis, osteoporosis, ligament injury in the foot and leg,
    • Non-voluntary patients will be excluded from the scope.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients undergoing appendectomy surgery who received foot reflexology
The study will be carried out with 120 patients hospitalized after appendectomy surgery in the surgical clinic of Bartın State Hospital. In the postoperative period, patients will be divided into experimental (n = 60) and control (n = 60) groups by block randomization with a computer-aided program.
Other: Foot Reflexology
In previous studies, no study was found investigating the effect of foot reflexology on sleep quality and bowel functions in patients undergoing surgical intervention. This study is thought to be the first to evaluate the effect of foot reflexology on sleep quality and bowel functions in surgical patients. In this respect, it is a study that will contribute to the literature.
Other Names:
  • Reflexology
  • Foot
No Intervention: Patients who underwent appendectomy surgery without foot reflexology
The study will be carried out with 120 patients hospitalized after appendectomy surgery in the surgical clinic of Bartın State Hospital. In the postoperative period, patients will be divided into experimental (n = 60) and control (n = 60) groups by block randomization with a computer-aided program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Effect of Foot Reflexology on Pain Intensity
Time Frame: initial postoperative evaluation, 1st hour and 3rd hour

In this study, foot reflexology will be applied to patients who have undergone appendectomy surgery. After this reflexology, patients' pain intensity will be evaluated. When the patients come out of appendectomy surgery, their pain will be evaluated with visual analog scale(VAS). Then, no intervention will be applied to the control group. Foot reflexology massage will be applied to the patients in the intervention group at the 1st hour postoperatively and pain values will be measured with VAS at 5 minutes, 30 minutes and 60 minutes after this application. At the 3rd hour postoperatively, reflexology massage will be performed for the 2nd time and pain intensity will be evaluated with VAS at 5 minutes, 30 minutes and 60 minutes after the re-massage.

VAS pain score is evaluated as "no pain" (score=0) and "worst pain" (score=10). score <3 is reported as mild pain, 3-6 as mild-moderate pain and >6 as moderate-severe pain.
initial postoperative evaluation, 1st hour and 3rd hour
The Effect of Foot Reflexology on Sleep Quality
Time Frame: 24 hours after surgery

After appendectomy surgery, no intervention will be applied to the control group, while foot reflexology will be applied to the intervention group at the 1st and 3rd hour after surgery. At 24 hours, the sleep quality of the intervention and control group patients will be evaluated with the Richard Cambple Sleep Scale.

Richard Campbell sleep scale consists of 6 items. Total scoring is based on the first 5 items. Each item is evaluated on a scale of 0-100 with the visual analog scale technique. A score of 0-25 on the scale indicates very poor sleep and 76-100 indicates very good sleep.
24 hours after surgery
The Effect of Foot Reflexology on Bowel Function
Time Frame: initial postoperative evaluation, 1st hour and 3rd hour
After appendectomy, bowel functions of the control and intervention groups will be evaluated. Afterwards, foot reflexology will be applied to the intervention group at the 1st and 3rd hour and their bowel functions will be evaluated on the bowel monitoring form. The control group will be evaluated at the 1st hour and 3rd hour after surgery without any intervention. Bowel functions will be recorded on the bowel function monitoring form created by the researcher. This form includes parameters such as the time of the first flatulence, the time of the first defecation, the time of oral feeding, and the time of the first mobilization.
initial postoperative evaluation, 1st hour and 3rd hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bartın Unıversity

Investigators

  • Study Director: Sevim ÇELİK, Prof, Bartın University Health Science Faculty

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Actual)

January 1, 2024

Study Completion (Actual)

January 10, 2024

Study Registration Dates

First Submitted

February 2, 2024

First Submitted That Met QC Criteria

May 6, 2024

First Posted (Actual)

May 9, 2024

Study Record Updates

Last Update Posted (Actual)

May 9, 2024

Last Update Submitted That Met QC Criteria

May 6, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BartınU-SBF-BKÇ-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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