Investigation of the Effects of Aromatherapy Foot Massage on Postoperative Pain, Sleep, and Recovery in Laparoscopic Cholecystectomy

January 15, 2026 updated by: Ümmügülsüm Dursun, Ataturk University
This randomized controlled study aims to evaluate the effects of aromatherapy foot massage on postoperative pain, sleep quality, and recovery in patients undergoing laparoscopic cholecystectomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a randomized controlled trial conducted in patients undergoing laparoscopic cholecystectomy. Eligible patients are randomly assigned to either an aromatherapy foot massage group or a control group receiving standard postoperative care.

In the intervention group, aromatherapy foot massage is applied to both feet for 10 minutes approximately one hour after surgery and repeated six hours later. The control group receives routine postoperative care without massage.

Pain intensity is assessed using the Visual Analog Scale (VAS). Sleep quality is assessed using the Visual Sleep Scale, and postoperative recovery is assessed using the Postoperative Recovery Index. Measurements are performed preoperatively and during the postoperative period according to the study protocol.

The study is conducted in accordance with ethical principles, and written informed consent is obtained from all participants.

Study Type

Interventional

Enrollment (Actual)

103

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 (Türkiye)
      • Erzurum, Turkey (Türkiye)
        • Atatürk University Research and Application Center

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:

  • Adults aged 18 years and older
  • Patients undergoing laparoscopic cholecystectomy
  • Able to communicate and provide informed consent
  • Willing to participate in the study

Exclusion Criteria:

  • Patients with cognitive impairment or communication difficulties
  • Patients with chronic pain disorders
  • Patients using continuous analgesic or sedative medication
  • Patients with complications requiring intensive care
  • Patients who decline to participate

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aromatherapy foot massage
Patients receiving aromatherapy foot massage in addition to standard postoperative care
Other: aromatherapy foot massage
Aromatherapy foot massage applied to both feet for 10 minutes approximately one hour after surgery and repeated six hours later.
No Intervention: control
Patients receiving standard postoperative care without aromatherapy massage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain intensity (VAS score)
Time Frame: 5, 30, 60, 90, and 120 minutes after the massage session and on postoperative Day 1
Pain intensity was assessed using the Visual Analog Scale (VAS), a 10-cm horizontal line ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity.
5, 30, 60, 90, and 120 minutes after the massage session and on postoperative Day 1
postoperative recovery (postoperative recovery ındex score)
Time Frame: Baseline (preoperative) and postoperative Day 1
Postoperative recovery was assessed using the Postoperative Recovery Index (PRI), a validated questionnaire used to evaluate patients' recovery after surgery. Higher scores indicate better postoperative recovery.
Baseline (preoperative) and postoperative Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sleep quality (visual sleep scale score)
Time Frame: Baseline (preoperative) and postoperative Day 1
Sleep quality was assessed using the Visual Sleep Scale (VSS), a self-reported scale used to evaluate perceived sleep quality. Higher scores indicate better sleep quality.
Baseline (preoperative) and postoperative Day 1

Collaborators and Investigators

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

Sponsor

Ataturk University

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)

October 1, 2023

Primary Completion (Actual)

March 1, 2024

Study Completion (Actual)

March 1, 2024

Study Registration Dates

First Submitted

December 22, 2025

First Submitted That Met QC Criteria

January 15, 2026

First Posted (Actual)

January 23, 2026

Study Record Updates

Last Update Posted (Actual)

January 23, 2026

Last Update Submitted That Met QC Criteria

January 15, 2026

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023/47

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be shared in an anonymized form upon request from researchers.

IPD Sharing Time Frame

From study completion

IPD Sharing Access Criteria

•Who can access it: Authorized researchers and academic institutions. • Conditions: • Requesting researchers must obtain ethical committee approval from their institution. • Data will be shared in an anonymized form and for research purposes only. • Requests must be made in writing via PRS.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

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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