ClinicalTrials.gg
CompletedNCT07363668Updated Jan 23, 2026

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

An interventional study of aromatherapy foot massage in Cholelithiasis, Cholecystitis and Gallbladder Diseases, sponsored by Ataturk University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-23.

Sponsored by Ataturk University · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 2 years 2 months after the study started (first participant enrolled Oct 2023, registered Dec 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
103
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cholelithiasis
  • Cholecystitis
  • Gallbladder Diseases
  • Postoperative Pain

Keywords

  • Nursing
  • Aromatherapy
  • Foot massage
  • Laparoscopic cholecystectomy
  • Sleep quality
  • Postoperative recovery
03

In context

Cholelithiasis

189 studies on the registry are indexed under Cholelithiasis; 42 are open to participants now.

This study's enrollment of 103 is above the median of 90 across 135 interventional studies indexed under Cholelithiasis.

Browse Cholelithiasis studies →

Lead sponsor

Ataturk University is the lead sponsor of 458 studies on the registry; 124 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
103 participants (actual)

Study arms

  • Experimental
    Aromatherapy foot massage

    Patients receiving aromatherapy foot massage in addition to standard postoperative care

    Other: aromatherapy foot massage

  • No intervention
    control

    Patients receiving standard postoperative care without aromatherapy massage

Interventions

  • Otheraromatherapy foot massage

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 5, 30, 60, 90, and 120 minutes after the massage session and on postoperative Day 1

  2. 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.

    Time frame: Baseline (preoperative) and postoperative Day 1

Secondary outcomes

  1. sleep quality (visual sleep scale score)

    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.

    Time frame: Baseline (preoperative) and postoperative Day 1

07

Study locations

1 site
  • Atatürk University Research and Application Center
    Erzurum, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: Yes — Data will be shared in an anonymized form upon request from researchers.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, 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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07363668
Lead sponsor
Ataturk University
Responsible party
Ümmügülsüm Dursun (Msc, Ataturk University) — Principal investigator
First posted
Jan 23, 2026
Start date
Oct 1, 2023
Primary completion
Mar 1, 2024
Completion
Mar 1, 2024
Last update
Jan 23, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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