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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reflexology | Experimental | Symptomatic 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 | Symptomatic hospitalized people randomized to sham reflexology on top of standard of care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reflexology | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline and 4 hours post treatment: calculated as value at 4 hours post treatment minus value at baseline |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elad Schiff, Prof | Director, Internal Medicine B | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bnai Zion Medical Center | Haifa | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41020221 | Derived | 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. | |
| 31126575 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Reflexology | Symptomatic hospitalized people randomized to reflexology on top of standard of care Reflexology: 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. |
| FG001 | Standard of Care Only | Symptomatic hospitalized people randomized to standard of care only |
| FG002 | Sham Reflexology | Symptomatic hospitalized people randomized to sham reflexology on top of standard of care Sham reflexology: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Reflexology | Symptomatic hospitalized people randomized to reflexology on top of standard of care Reflexology: 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Deviation | units on VAS-A scale | Baseline and 4 hours post treatment: calculated as value at 4 hours post treatment minus value at baseline |
|
From baseline and until 1 year after recruitment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Reflexology | Symptomatic hospitalized people randomized to reflexology on top of standard of care Reflexology: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Samuel Attias | Bnai Zion Medical Center | +972524707304 | samuel.attias@b-zion.org.il |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 15, 2016 | Feb 23, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D009325 | Nausea |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
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| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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| Sham reflexology | Other | 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. |
|
| Derived |
| Schiff 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. |
| Standard of Care Only |
Symptomatic hospitalized people randomized to standard of care only |
| BG002 | Sham Reflexology | Symptomatic hospitalized people randomized to sham reflexology on top of standard of care Sham reflexology: 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Number (percentage) of patients who received Anxiolytics: Diazepam or Oxazepam | Count of Participants | Participants |
|
Symptomatic hospitalized people randomized to standard of care only
| OG002 | Sham Reflexology | Symptomatic hospitalized people randomized to sham reflexology on top of standard of care Sham reflexology: 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. |
|
|
| 0 |
| 101 |
| 0 |
| 101 |
| 0 |
| 101 |
| EG001 | Standard of Care Only | Symptomatic hospitalized people randomized to standard of care only | 0 | 100 | 0 | 100 | 0 | 100 |
| EG002 | Sham Reflexology | Symptomatic hospitalized people randomized to sham reflexology on top of standard of care Sham reflexology: 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. | 0 | 99 | 0 | 99 | 0 | 99 |
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| D001523 | Mental Disorders |
| Male |
|