Postoperative PainNCT07770295
Effects of Foot Reflexology on Postoperative Pain, Anxiety, Nausea, and Vomiting Among Patients After Laparoscopic Cholecystectomy
A study testing Foot reflexology in people with Postoperative Pain and Anxiety, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study aims to evaluate the effect of foot reflexology on pain, anxiety, nausea, and vomiting among patients after laparoscopic cholecystectomy. Participants will receive foot reflexology in addition to routine postoperative care, and outcomes will be assessed using appropriate measures before and after the… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Postoperative Pain, Anxiety, Nausea
- What is being tested?
- Foot reflexology
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2024to 30 Apr 2025
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients aged 18 years and older undergoing laparoscopic surgery.
- Patients who are conscious, oriented, and able to communicate.
- Patients who provide informed consent to participate in the study.
Who cannot join
- Patients with foot lesions, skin infections, fractures, or deep vein thrombosis (DVT) in the lower extremities.
- Patients with severe neurological deficits or neuropathy affecting the lower limbs.
- Patients with a history of severe cognitive impairment or psychiatric disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Foot Reflexology on Postoperative Pain, Anxiety, Nausea, and Vomiting Among Patients After Laparoscopic Cholecystectomy: A Quasi-experimental, Non-randomized Controlled Pretest-Posttest Study
This study aims to evaluate the effect of foot reflexology on pain, anxiety, nausea, and vomiting among patients after laparoscopic cholecystectomy. Participants will receive foot reflexology in addition to routine postoperative care, and outcomes will be assessed using appropriate measures before and after the intervention.
Read the detailed description
Laparoscopic cholecystectomy is a commonly performed surgical procedure that may be associated with postoperative pain, anxiety, nausea, and vomiting. These symptoms can negatively affect patients' comfort and recovery. This study evaluates the effect of foot reflexology as a complementary nursing intervention on pain, anxiety, nausea, and vomiting among patients following laparoscopic cholecystectomy.
The study uses a quasi-experimental design. Eligible patients undergoing laparoscopic cholecystectomy will be recruited according to the predefined inclusion and exclusion criteria and allocated to the study and comparison groups according to the study protocol. The intervention group will receive foot reflexology in addition to routine postoperative care, while the comparison group will receive routine postoperative care. Pain, anxiety, nausea, and vomiting will be assessed using the study's specified assessment tools. Outcomes will be compared between groups to determine the effect of foot reflexology.
- Conditions
- Postoperative Pain, Anxiety, Nausea, Vomiting, Laparoscopic Cholecystectomy
- Being tested
- Foot reflexology
- Keywords
- Foot Reflexology, Laparoscopic Cholecystectomy, Postoperative pain, Anxiety, Nausea, Vomiting
- Medical subject headings
- Pain, Postoperative, Anxiety Disorders, Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foot reflexologyProcedure or surgery
"Participants receive a 20-minute foot reflexology session (10 minutes per foot) targeting specific reflex zones in addition to standard postoperative nursing care
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | "Participants receive routine postoperative nursing care and prescribed analgesics/antiemetics per hospital protocol, without receiving foot reflexology |
| Foot Reflexology group | Experimental | "Participants receive a 20-minute foot reflexology session (10 minutes per foot) in addition to standard postoperative nursing care Receives: Procedure: Foot reflexology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative pain
Assess pain intensity by using Numeric Pain Rating Scale
Measured: Baseline preintervention and 30,90,120 minutes after intervention
Secondary outcomes (2)
Anxiety
Burn anxiety inventory using to assess anxiety
Measured: Baseline preintervention and after 120 minutes after intervention
Nausea and Vomiting
Assess nausea and vomiting by using Nausea and vomiting grading scale
Measured: Baseline preintervention and 30,90,120 minutes after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start15 Oct 2024
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A quasi-experimental, two-group parallel study comparing patients receiving foot reflexology with a control group receiving routine postoperative care.
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hanan Sayed Ali, Study director, Faculty of Nursing Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07770295
- Sponsor's protocol ID
- 25.02.566
- Status last verified
- Aug 2026
- First submitted
- 9 Aug 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Foot Reflexology on Postoperative Pain, Anxiety, Nausea, and Vomiting Among Patients After Laparoscopic Cholecystectomy: A Quasi-experimental, Non-randomized Controlled Pretest-Posttest Study
- ClinicalTrials.gov ID
- NCT07770295
- Acronym / sponsor ID
- 25.02.566
- Conditions
- Postoperative Pain, Anxiety, Nausea, Vomiting, Laparoscopic Cholecystectomy
- Keywords
- Foot Reflexology, Laparoscopic Cholecystectomy, Postoperative pain, Anxiety, Nausea, Vomiting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 18 Aug 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 study aims to evaluate the effect of foot reflexology on pain, anxiety, nausea, and vomiting among patients after laparoscopic cholecystectomy. Participants will receive foot reflexology in addition to routine postoperative care, and outcomes will be assessed using appropriate measures before and after the intervention.
Detailed description
Laparoscopic cholecystectomy is a commonly performed surgical procedure that may be associated with postoperative pain, anxiety, nausea, and vomiting. These symptoms can negatively affect patients' comfort and recovery. This study evaluates the effect of foot reflexology as a complementary nursing intervention on pain, anxiety, nausea, and vomiting among patients following laparoscopic cholecystectomy.
The study uses a quasi-experimental design. Eligible patients undergoing laparoscopic cholecystectomy will be recruited according to the predefined inclusion and exclusion criteria and allocated to the study and comparison groups according to the study protocol. The intervention group will receive foot reflexology in addition to routine postoperative care, while the comparison group will receive routine postoperative care. Pain, anxiety, nausea, and vomiting will be assessed using the study's specified assessment tools. Outcomes will be compared between groups to determine the effect of foot reflexology.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A quasi-experimental, two-group parallel study comparing patients receiving foot reflexology with a control group receiving routine postoperative care.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –"Participants receive routine postoperative nursing care and prescribed analgesics/antiemetics per hospital protocol, without receiving foot reflexology |
| Foot Reflexology group | Experimental | Procedure: Foot reflexology"Participants receive a 20-minute foot reflexology session (10 minutes per foot) in addition to standard postoperative nursing care |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adult patients aged 18 years and older undergoing laparoscopic surgery.
- Patients who are conscious, oriented, and able to communicate.
- Patients who provide informed consent to participate in the study.
Key exclusion criteria (3 listed)
- Patients with foot lesions, skin infections, fractures, or deep vein thrombosis (DVT) in the lower extremities.
- Patients with severe neurological deficits or neuropathy affecting the lower limbs.
- Patients with a history of severe cognitive impairment or psychiatric disorders.
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 |
|---|---|---|
| Foot reflexology"Participants receive a 20-minute foot reflexology session (10 minutes per foot) targeting specific reflex zones in addition to standard postoperative nursing care | Procedure or surgery | Foot Reflexology group |
Primary outcome
Post operative pain
Time frame: Baseline preintervention and 30,90,120 minutes after intervention
Assess pain intensity by using Numeric Pain Rating Scale
2 secondary outcomes
Anxiety
Time frame: Baseline preintervention and after 120 minutes after intervention
Nausea and Vomiting
Time frame: Baseline preintervention and 30,90,120 minutes after intervention
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 18 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Hanan Sayed Ali study director
Faculty of Nursing Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foot reflexology in people with Postoperative Pain and Anxiety, run by Ain Shams University at 1 site in Egypt.
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 3 inclusion and 3 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 18 Aug 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 Egypt. 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?
Post operative pain (time frame: Baseline preintervention and 30,90,120 minutes after intervention). 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 18 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.