NCT07363668

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

December 22, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 23, 2026

Completed
Last Updated

January 23, 2026

Status Verified

June 1, 2023

Enrollment Period

5 months

First QC Date

December 22, 2025

Last Update Submit

January 15, 2026

Conditions

CholelithiasisCholecystitisGallbladder DiseasesPostoperative Pain

Keywords

NursingAromatherapyFoot massageLaparoscopic cholecystectomySleep qualityPostoperative recovery

Outcome Measures

Primary Outcomes (2)

  • pain intensity (VAS score)

    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)

    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 Outcomes (1)

  • sleep quality (visual sleep scale score)

    Baseline (preoperative) and postoperative Day 1

Study Arms (2)

Aromatherapy foot massage

EXPERIMENTAL

Patients receiving aromatherapy foot massage in addition to standard postoperative care

Other: aromatherapy foot massage

control

NO INTERVENTION

Patients receiving standard postoperative care without aromatherapy massage

Interventions

aromatherapy foot massageOTHER

Aromatherapy foot massage applied to both feet for 10 minutes approximately one hour after surgery and repeated six hours later.

Aromatherapy foot massage

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atatürk University Research and Application Center

Erzurum, Turkey (Türkiye)

Location

MeSH Terms

Conditions

CholelithiasisCholecystitisGallbladder DiseasesPain, PostoperativeSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Msc

Study Record Dates

First Submitted

December 22, 2025

First Posted

January 23, 2026

Study Start

October 1, 2023

Primary Completion

March 1, 2024

Study Completion

March 1, 2024

Last Updated

January 23, 2026

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
From study completion
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.

Locations

TU(1)