NCT07727291

Brief Summary

This study was conducted as a randomised controlled trial to determine the effect of virtual reality headset (VR) and the Benson Relaxation Technique (BRT) on anxiety and happiness levels in patients who have undergone bariatric surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 10, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 27, 2026

Completed
Last Updated

August 18, 2026

Status Verified

July 1, 2026

Enrollment Period

11 months

First QC Date

July 20, 2026

Last Update Submit

August 15, 2026

Conditions

Keywords

Anxietybariatric surgeryBenson relaxation techniquehappinessvirtual reality

Outcome Measures

Primary Outcomes (1)

  • State-Trait Anxiety Inventory (STAI Form Tx - I)

    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 Outcomes (1)

  • Oxford Happiness Questionnaire-Short Form (OHQ-SF)

    two weeks

Study Arms (3)

VR group

EXPERIMENTAL

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.

Behavioral: Experimental: VR group

Benson Relaxation Techniques group

EXPERIMENTAL

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

Behavioral: Experimental: Benson Relaxation Techniques group

Control group

NO INTERVENTION

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.

Interventions

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.

VR group

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

Benson Relaxation Techniques group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients under 18 years of age
  • those using non-pharmacological methods during .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Firat Universty

Elâzığ, 23119, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • DİLEK GÜNEŞ, associate professor

    Firat University

    PRINCIPAL INVESTIGATOR
  • Acar

    Firat University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single (Participant) By drawing lots, the first set was chosen to correspond to the experimental group and the second set to correspond to the control group for the two groups.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This randomised controlled experimental study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 20, 2026

First Posted

July 27, 2026

Study Start

December 10, 2024

Primary Completion

November 10, 2025

Study Completion

May 10, 2026

Last Updated

August 18, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations