- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07296679
The Effect of Hand Massage on Anxiety and Comfort of Bariatric Surgery Patients: A Randomised Controlled Trial
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
-
Elâzığ, Turkey (Türkiye), 23119
- Firat Universty
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion criteria:
- Aged 18 or older
- Not having a speech problem or hearing loss
- Not having any condition that would reduce comprehension and understanding abilities
- Agreeing to participate in the study
- Having a body mass index (BMI) ≥ 30.
Exclusion criteria:
- Having compromised tissue and skin on the forearm or hands (e.g., wounds, eczema, inflammation, phlebitis, arthritis, and rashes)
- Having an intravenous catheter in the back of the hand.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental group
Upon admission to the General Surgery clinic, patients were apprised of the study's objective, and their written and verbal agreement was acquired. Prior to the preoperative hand massage, the Patient Information Form, State-Trait Anxiety Inventory (STAI), and Short Form General Comfort Questionnaire (SGCQ) were administered to the patients in the general surgery clinic's patient room via face-to-face interviews. The patient rooms were single-occupancy, naturally lit, windowed, calm, quiet, and located within the clinic. Immediately before surgery, classic massage techniques including petrissage, friction, and kneading were applied to both hands for 10 minutes using baby oil on the palms, backs of the hands, and fingers. The hand massage was performed while the patient was in bed. The application lasted approximately 25 minutes. After the hand massage, State-Trait Anxiety Inventory (STAI) and General Comfort Scale-Short Form (SGCQ) were administered to the patients as post-test. |
Upon admission to the General Surgery clinic, patients were apprised of the study's objective, and their written and verbal agreement was acquired.
Prior to the preoperative hand massage, the Patient Information Form, State-Trait Anxiety Inventory (STAI), and Short Form General Comfort Questionnaire (SGCQ) were administered to the patients in the general surgery clinic's patient room via face-to-face interviews.
The patient rooms were single-occupancy, naturally lit, windowed, calm, quiet, and located within the clinic.
Immediately before surgery, classic massage techniques including petrissage, friction, and kneading were applied to both hands for 10 minutes using baby oil on the palms, backs of the hands, and fingers.
The hand massage was performed while the patient was in bed.
The application lasted approximately 25 minutes.
After the hand massage, State-Trait Anxiety Inventory (STAI) and General Comfort Scale-Short Form (SGCQ) were administered to the patients as post-test.
Other Names:
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No Intervention: Control group
No intervention other than the clinic protocol was applied to this group.
In the control group, Patient Information Form, State-Trait Anxiety Inventory (STAI), General Comfort Scale-Short Form (SGCQ) were administered as pre-test before the operation.
Just before the operation, State-Trait Anxiety Inventory (STAI) and General Comfort Scale-Short Form were administered as post-test.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
State Anxiety Inventory (STAI)
Time Frame: two weeks
|
The scale was developed by Spielberger et al.
Reliability and validity were carried out by Öner and Le Compte.
The scale consists of two sub-units that measure anxiety separately, but in this study, the state anxiety scale that the individual feels indirectly from the stressful situation will be used.
It is a 4-point Likert-type scale consisting of 20 items and short statements.
The total score obtained from the scale varies between 20 and 80, and a high score indicates a high level of anxiety.
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two weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
General Comfort Scale-Short Form (SGCQ)
Time Frame: two weeks
|
It was developed by Kolcaba to determine the comfort requirements of the individual.
The Turkish validity and reliability study of the scale was conducted by Sarıtaş et al.
In the evaluation of the scale, negative items (items 2, 3, 7, 9, 11, 18, 20, 21, 23, 24, 27) are reverse coded and summed.
This 6-point Likert-type scale consisting of 28 items consists of three sub-dimensions: refreshment (1-9 items), relaxation (10-18 items) and superiority (19-28 items).
The lowest score that can be obtained from the scale is 28 and the highest score is 168.
As the score obtained from the scale decreases, it indicates that the comfort level of the individual is low.
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two weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: DİLEK GÜNEŞ, FIRAT ÜNİVERSİTESİ
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FiratOU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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