- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07727291
The Effect of Virtual Reality Intervention and the Benson Relaxation Technique on Anxiety and Happiness
The Effect of Virtual Reality Intervention and the Benson Relaxation Technique on Anxiety and Happiness in the Period After Bariatric Surgery: A Randomised Controlled Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Elâzığ, Turkey (Türkiye), 23119
- Firat Universty
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria: - Patients who had undergone bariatric surgery- were 18 years of age or older- had no communication difficulties- had no psychiatric disorders- had not experienced any complications during or after surgery- did not use any other non-pharmacological approaches during.
Exclusion Criteria: - Patients under 18 years of age - those using non-pharmacological methods during .
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: VR group
The Patient Information Form, STAI Form TX-I, and OHQ-SF were administered as pretests.
Following the pretests, patients were shown a video of a nature scene using VR accompanied by nature sounds for an average of 20 minutes.
A quiet environment was prepared before the virtual reality headset session to ensure patients could relax and remain focused.
The researcher ensured hand hygiene and equipment disinfection throughout the session.
The headset was adjusted to fit each patient's head circumference.
Image clarity, lens settings, and sound levels were adjusted according to individual preferences.
The intervention was administered twice daily-morning and evening-for three days during the postoperative period, totaling six sessions.
Immediately following the final session, the STAI Form Tx-I and OHQ-SF were administered as posttests.
|
Experimental: VR group Arm Description: The Patient Information Form, STAI Form TX-I, and OHQ-SF were administered as pretests.
Following the pretests, patients were shown a video of a nature scene using VR accompanied by nature sounds for an average of 20 minutes.
A quiet environment was prepared before the virtual reality headset session to ensure patients could relax and remain focused.
The researcher ensured hand hygiene and equipment disinfection throughout the session.
The headset was adjusted to fit each patient's head circumference.
Image clarity, lens settings, and sound levels were adjusted according to individual preferences.
The intervention was administered twice daily-morning and evening-for three days during the postoperative period, totaling six sessions.
Immediately following the final session, the STAI Form Tx-I and OHQ-SF were administered as posttests.
|
|
Experimental: Benson Relaxation Techniques group
The patient information form, STAI Form TX-I, and OHQ-SF pretest were administered. Patients were ensured to be in a comfortable position during the Benson Relaxation Technique session. The environment was prepared to be quiet, dimly lit, and free of distractions. Before beginning the relaxation exercise, patients were instructed to focus entirely on their breathing. The researcher provided the commands for the relaxation exercise in a tone of voice audible to the patients. Instructions: Choose a short sentence or a word that is meaningful to you and helps you focus your attention; close your eyes; relax all your muscles, starting with your feet and slowly moving upward through your muscle groups; breathe gently and naturally; as you exhale, silently repeat your focus word or sentence to yourself; tell yourself, "Everything is fine" and "I feel light, healthy, and energetic"; and calmly focus on your breath and your muscles. Focus on relaxing and letting go until the instructions are |
Experimental: Benson Relaxation Techniques group Arm Description: The patient information form, STAI Form TX-I, and OHQ-SF pretest were administered.
Patients were ensured to be in a comfortable position during the Benson Relaxation Technique session.
The environment was prepared to be quiet, dimly lit, and free of distractions.
Before beginning the relaxation exercise, patients were instructed to focus entirely on their breathing.
The researcher provided the commands for the relaxation exercise in a tone of voice audible to the patients.
Instructions: Choose a short sentence or a word that is meaningful to you and helps you focus your attention; close your eyes; relax all your muscles, starting with your feet and slowly moving upward through your muscle groups; breathe gently and naturally; as you exhale, silently repeat your focus word or sentence to yourself; tell yourself, "Everything is fine" and "I feel light, healthy, and energetic"; and calmly focus on your breath and your musc
|
|
No Intervention: Control group
For patients in the control group, the data collection instruments were administered as a pretest.
No intervention was performed on this patient group.
Three days after the pretest, the STAI Form Tx-I and OHQ-SF were also administered to patients in the control group as a posttest.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
State-Trait Anxiety Inventory (STAI Form Tx - I)
Time Frame: two weeks
|
This scale was developed by Spielberger et al.
Its reliability and validity in Turkey were established by Öner and Le Compte .
The scale's Cronbach's Alpha value is 0.83.
The scale includes both direct and reverse-scored items.
During scoring, the total weights for the direct and reverse-scored items are calculated separately; then, the total score for the direct items is subtracted from the total score for the reverse-scored items.
The total score on the scale ranges from 20 to 80; a high score indicates a high level of anxiety, while a low score indicates a low level of anxiety.
|
two weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Oxford Happiness Questionnaire-Short Form (OHQ-SF)
Time Frame: two weeks
|
A unidimensional questionnaire developed by Hills and Argyle to assess levels of happiness .
The questionnaire was translated into Turkish by Doğan and Çötok.
Scores on the questionnaire range from 7 to 35.
A higher score indicates a higher level of happiness.
The Cronbach's alpha value for the questionnaire was found to be 0.74 .
|
two weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: DİLEK GÜNEŞ, associate professor, Firat University
- Study Chair: Acar, Firat University
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- DGunes
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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