CholelithiasisNCT07363668
Investigation of the Effects of Aromatherapy Foot Massage on Postoperative Pain, Sleep, and Recovery in Laparoscopic Cholecystectomy
A study testing aromatherapy foot massage in people with Cholelithiasis and Cholecystitis, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholelithiasis, Cholecystitis, Gallbladder Diseases
- What is being tested?
- aromatherapy foot massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years and older
- Patients undergoing laparoscopic cholecystectomy
- Able to communicate and provide informed consent
- Willing to participate in the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Atatürk University Research and Application Center
Erzurum
About this study
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.
- Being tested
- aromatherapy foot massage
- Keywords
- Nursing, Aromatherapy, Foot massage, Laparoscopic cholecystectomy, Sleep quality, Postoperative recovery
- Medical subject headings
- Cholelithiasis, Cholecystitis, Gallbladder Diseases, Pain, Postoperative, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aromatherapy foot massageOther
Aromatherapy foot massage applied to both feet for 10 minutes approximately one hour after surgery and repeated six hours later.
| Study group | Role | What they receive |
|---|---|---|
| Aromatherapy foot massage | Experimental | Patients receiving aromatherapy foot massage in addition to standard postoperative care Receives: Other: aromatherapy foot massage |
| control | No intervention | Patients receiving standard postoperative care without aromatherapy massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline (preoperative) and postoperative Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start1 Oct 2023
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholelithiasisStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ümmügülsüm Dursun, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07363668
- Sponsor's protocol ID
- 2023/47
- Status last verified
- Jun 2023
- First submitted
- 22 Dec 2025
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared in an anonymized form upon request from researchers.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Aromatherapy Foot Massage on Postoperative Pain, Sleep, and Recovery in Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT07363668
- Acronym / sponsor ID
- 2023/47
- Keywords
- Nursing, Aromatherapy, Foot massage, Laparoscopic cholecystectomy, Sleep quality, Postoperative recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aromatherapy foot massage | Experimental | Other: aromatherapy foot massagePatients receiving aromatherapy foot massage in addition to standard postoperative care |
| control | No intervention | –Patients receiving standard postoperative care without aromatherapy massage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 years and older
- Patients undergoing laparoscopic cholecystectomy
- Able to communicate and provide informed consent
- Willing to participate in the study
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aromatherapy foot massageAromatherapy foot massage applied to both feet for 10 minutes approximately one hour after surgery and repeated six hours later. | Other | Aromatherapy foot massage |
Primary outcome
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.
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.
1 secondary outcome
sleep quality (visual sleep scale score)
Time frame: Baseline (preoperative) and postoperative Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: Yes. Data will be shared in an anonymized form upon request from researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aromatherapy foot massage in people with Cholelithiasis and Cholecystitis, run by Ataturk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain intensity (VAS score) (time frame: 5, 30, 60, 90, and 120 minutes after the massage session and on postoperative Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.