PainNCT01733771
The Effect of Complementary Medicine (CAM) Treatments on Common Symptoms in Hospitalized Patients
A study testing Reflexology in people with Pain and Nausea, run by Bnai Zion Medical Center at 1 site in Israel.
Trial summary
This is a randomized, single blinded, interventional trial conducted in patients undergoing elective laparoscopic cholecystectomy, comparing the following three groups: Controls receiving standard-of-care (SoC) only (Group 1); intervention group receiving reflexology and SoC (Group 2); and a group receiving sham… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Reflexology
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2010to 30 Dec 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients aged 18 years
- Undergoing Laparoscopic Cholecysyectomy (LC)
Who cannot join
- Patients with a history of obstructive sleep apnea
- Contraindication for benzodiazepines
- Hemodynamic instability
- Leg ulcers
- Patients undergoing a LC together with another surgical procedure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Reported Outcomes Following Complementary Medicine Treatments in Hospitalized Patients
This is a randomized, single blinded, interventional trial conducted in patients undergoing elective laparoscopic cholecystectomy, comparing the following three groups: Controls receiving standard-of-care (SoC) only (Group 1); intervention group receiving reflexology and SoC (Group 2); and a group receiving sham reflexology and SoC (Group 3). In all groups, level of preoperative anxiety was evaluated at entry and exit from the Holding Room Area (HRA). The evaluation was carried out using the Visual Analogue Scale for Anxiety (VAS-A) questionnaire.
- Being tested
- Reflexology, Sham reflexology
- Keywords
- complementary medicine, hospitalized
- Medical subject headings
- Pain, Nausea, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReflexologyOther
Reflexology intervention involved a 15-minute treatment in the induction room, provided by three reflexologists from the hospital staff. The reflexology protocol was developed through a Delphi method.
Sham reflexologyOther
Sham reflexology intervention were given by two complementary medicine practitioners with knowledge in touch therapy (shiatsu) and included 15 minutes of gentle, nonspecific foot massage. Similarly to the true reflexology protocol, the protocol for this treatment was also determined in a consensus-reaching process among a group of four experienced reflexologists.
| Study group | Role | What they receive |
|---|---|---|
| Reflexology | Experimental | Symptomatic hospitalized people randomized to reflexology on top of standard of care Receives: Other: Reflexology |
| Standard of care only | No intervention | Symptomatic hospitalized people randomized to standard of care only |
| Sham reflexology | Sham comparator | Symptomatic hospitalized people randomized to sham reflexology on top of standard of care Receives: Other: Sham reflexology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative Anxiety Expressed in Visual Analogue Scale for Anxiety (VAS-A) From 0 (Asymptomatic: no Anxiety) to 10 Extremely Symptomatic Anxiety
Change of VAS-A between baseline and 4 hours post-treatment
Measured: Baseline and 4 hours post treatment: calculated as value at 4 hours post treatment minus value at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2012 (estimated)
- Study startApr 2010
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bnai Zion Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Elad Schiff, Prof, Principal investigator, Director, Internal Medicine B
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01733771
- Sponsor's protocol ID
- BNZ-0041-09
- Status last verified
- Jul 2019
- First submitted
- 10 Jul 2012
- Last updated
- 20 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Samuel A, Lital KB, Mostafa S, Ariel S, Yael G, Eran BA, Ibrahim M, Gideon S, Sagi G, Dan S, Elad S. Effectiveness of standard of care, vs. its combination with reflexology and sham reflexology on preoperative anxiety in patients undergoing elective laparoscopic cholecystectomy: a single-blinded randomized controlled trial. Front Med (Lausanne). 2025 Sep 12;12:1634575. doi: 10.3389/fmed.2025.1634575. eCollection 2025.
PubMed 41020221Schiff E, Attias S, Matter I, Sroka G, Nae B, Arnon Z, Samuels N, Grinberg O, Ben-Arye E. Complementary and alternative medicine interventions for perioperative symptoms: A comparative effectiveness study. Complement Ther Med. 2019 Jun;44:51-55. doi: 10.1016/j.ctim.2019.03.003. Epub 2019 Mar 21.
PubMed 31126575
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Reported Outcomes Following Complementary Medicine Treatments in Hospitalized Patients
- ClinicalTrials.gov ID
- NCT01733771
- Acronym / sponsor ID
- BNZ-0041-09
- Keywords
- complementary medicine, hospitalized
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Bnai Zion Medical CenterOther government
- Study start
- Apr 2010
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 27 Nov 2012 (estimated)
- Results
- Posted 20 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, single blinded, interventional trial conducted in patients undergoing elective laparoscopic cholecystectomy, comparing the following three groups: Controls receiving standard-of-care (SoC) only (Group 1); intervention group receiving reflexology and SoC (Group 2); and a group receiving sham reflexology and SoC (Group 3). In all groups, level of preoperative anxiety was evaluated at entry and exit from the Holding Room Area (HRA). The evaluation was carried out using the Visual Analogue Scale for Anxiety (VAS-A) questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Reflexology | Experimental | Other: ReflexologySymptomatic hospitalized people randomized to reflexology on top of standard of care |
| Standard of care only | No intervention | –Symptomatic hospitalized people randomized to standard of care only |
| Sham reflexology | Sham comparator | Other: Sham reflexologySymptomatic hospitalized people randomized to sham reflexology on top of standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged 18 years
- Undergoing Laparoscopic Cholecysyectomy (LC)
Key exclusion criteria (5 listed)
- Patients with a history of obstructive sleep apnea
- Contraindication for benzodiazepines
- Hemodynamic instability
- Leg ulcers
- Patients undergoing a LC together with another surgical procedure.
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 |
|---|---|---|
| ReflexologyReflexology intervention involved a 15-minute treatment in the induction room, provided by three reflexologists from the hospital staff. The reflexology protocol was developed through a Delphi method. | Other | Reflexology |
| Sham reflexologySham reflexology intervention were given by two complementary medicine practitioners with knowledge in touch therapy (shiatsu) and included 15 minutes of gentle, nonspecific foot massage. Similarly to the true reflexology protocol, the protocol for this treatment was also determined in a consensus-reaching process among a group of four experienced reflexologists. | Other | Sham reflexology |
Primary outcome
Perioperative Anxiety Expressed in Visual Analogue Scale for Anxiety (VAS-A) From 0 (Asymptomatic: no Anxiety) to 10 Extremely Symptomatic Anxiety
Time frame: Baseline and 4 hours post treatment: calculated as value at 4 hours post treatment minus value at baseline
Change of VAS-A between baseline and 4 hours post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41020221Samuel A, Lital KB, Mostafa S, Ariel S, Yael G, Eran BA, Ibrahim M, Gideon S, Sagi G, Dan S, Elad S. Effectiveness of standard of care, vs. its combination with reflexology and sham reflexology on preoperative anxiety in patients undergoing elective laparoscopic cholecystectomy: a single-blinded randomized controlled trial. Front Med (Lausanne). 2025 Sep 12;12:1634575. doi: 10.3389/fmed.2025.1634575. eCollection 2025.
- Derived from this study: PubMed 31126575Schiff E, Attias S, Matter I, Sroka G, Nae B, Arnon Z, Samuels N, Grinberg O, Ben-Arye E. Complementary and alternative medicine interventions for perioperative symptoms: A comparative effectiveness study. Complement Ther Med. 2019 Jun;44:51-55. doi: 10.1016/j.ctim.2019.03.003. Epub 2019 Mar 21.
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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.
Elad Schiff, Prof principal investigator
Director, Internal Medicine B
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reflexology in people with Pain and Nausea, run by Bnai Zion Medical Center at 1 site in Israel.
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 2 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 20 May 2025. 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 Israel. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 20 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Perioperative Anxiety Expressed in Visual Analogue Scale for Anxiety (VAS-A) From 0 (Asymptomatic: no Anxiety) to 10 Extremely Symptomatic Anxiety (time frame: Baseline and 4 hours post treatment: calculated as value at 4 hours post treatment minus value at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01733771, which also lists 2 linked publications.
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 20 May 2025.