NCT07152054

Brief Summary

This study will be conducted at the General Surgery Clinic of City Hospital in Erzurum between August 2025 and April 2026 using a randomized controlled experimental design. In the power analysis, it was determined that the sample of the study should be 70 patients in total, 35 patients in each group, with a medium effect size of 0.5% according to Cohen (42), a margin of error of 0.05%, a confidence interval of 0.95%, and a 95% universe representation power. Patients will be assigned to either the experimental or control groups using a random number generator using a two-block randomization method (random.org). Given that exposure to nature through virtual reality increases physiological arousal and promotes positive mood, the study aimed to evaluate the effects of virtual forest bathing on pre- and postoperative pain, anxiety, fear, sleep, vital signs, and cortisol levels in patients undergoing bariatric surgery.

Trial Health

65
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Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Aug 2025

Status
not yet recruiting

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 Progress81%
Aug 2025Aug 2026

First Submitted

Initial submission to the registry

August 10, 2025

Completed
15 days until next milestone

Study Start

First participant enrolled

August 25, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 3, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2026

Expected
Last Updated

September 3, 2025

Status Verified

August 1, 2025

Enrollment Period

4 months

First QC Date

August 10, 2025

Last Update Submit

August 28, 2025

Conditions

Outcome Measures

Primary Outcomes (6)

  • Personal Information Form:

    This questionnaire, developed by the researcher based on a literature review related to the topic, consists of 16 questions addressing variables such as gender, age, education level, marital status, and previous surgical history.

    up to 24 hours

  • Surgical Fear Questionnaire (SFQ)

    Surgical Fear Questionnaire (SFQ): Developed by Theunissen et al. in 2014 to assess the fear levels of patients scheduled for surgical procedures, this 8-item Likert-type scale evaluates short-term surgical fears with items 1-4 and long-term surgical fears with items 5-8. Each item is scored on a scale from 0 ("not afraid at all") to 10 ("very afraid"), resulting in a total score ranging from 0 to 80. Higher scores indicate greater levels of surgical fear (Theunissen et al., 2014). The Turkish validity and reliability study conducted by Bağdigen and Özlü (2018) reported a Cronbach's alpha coefficient of 0.93.

    up to 24 hours

  • Richard-Campbell Sleep Questionnaire (RCSQ)

    Developed by Richards in 1987 (Richards, 1987) and adapted into Turkish by Özlü and Özer in 2015 (Özlü \& Özer, 2015), this scale consists of six items evaluating sleep depth, time to fall asleep, frequency of awakenings, time to return to sleep after awakening, sleep quality, and environmental noise level. Each item is scored between 0 and 100. In total score calculation, the sixth item (noise level) is excluded, and scoring is based on the remaining five items. Higher scores indicate better sleep quality. Final scores are calculated by dividing the total score by the number of items. Scores between 0-25 indicate "very poor" sleep quality, while scores between 76-100 indicate "very good" sleep quality.

    up to 24 hours

  • Visual Analog Scale (VAS)

    Developed by Price et al. (1983), this scale measures the intensity of pain using a 10 cm vertical or horizontal line with endpoints labeled as "no pain" (0) and "worst possible pain" (10). The patient marks a point corresponding to their perceived pain intensity, and the distance from the "no pain" end to the marked point is measured in centimeters, representing the pain score. Higher scores indicate greater pain intensity.

    up to 24 hours

  • State-Trait Anxiety Inventory (STAI-STAII)

    It is a test developed by Spielberger et al. that measures state and trait anxiety levels. Its validity and reliability in Turkey was done by Oner and Le Compte. The scale consists of two parts, the 'state anxiety scale', which is created with the aim of determining the instantaneous feelings, and the 20-item 'trait anxiety scale', which was created to determine the feelings in general. It is a four degree scale ranging from 'Nothing' to 'All'. Scores range from 20 (low anxiety) to 80 (high anxiety).

    up to 24 hours

  • Tracking Form for Parameters

    Before and after bariatric surgery, patients' heart rate, blood pressure, and oxygen saturation will be measured and recorded in this form. In addition, to assess stress levels, blood cortisol measurements will be performed. Blood samples for cortisol will be collected in the morning (between 07:30-08:30) in appropriate tubes, promptly transported to the laboratory, and analyzed under cold chain conditions. Serum or plasma will be separated and analyzed using standard devices. All procedures will be carried out in the Erzurum City Hospital laboratory according to existing standard protocols and high-quality criteria, and results will be recorded.

    up to 24 hours

Study Arms (1)

Experimental: Virtual Forest Bathing

EXPERIMENTAL

Patients in the experimental group will undergo the routine surgical procedure implemented in the hospital, and their evaluations will be carried out using the predetermined questionnaires. In addition, they will receive a virtual forest bathing intervention on the evening prior to surgery and on the first postoperative day. On the day of admission for bariatric surgery, the researcher will administer, face-to-face, the Personal Information Form, Surgical Fear Questionnaire, Richard-Campbell Sleep Questionnaire, Visual Analog Scale (VAS) for pain assessment, State-Trait Anxiety Inventory, and the parameter recording form. Following the virtual forest bathing sessions conducted on the evening before surgery and on the first postoperative day, the Surgical Fear Questionnaire, Richard-Campbell Sleep Questionnaire, Visual Analog Scale (VAS), State-Trait Anxiety Inventory, and parameter recording form will be completed again.

Device: virtual forest bathing

Interventions

Virtual reality (VR) is an advanced computer technology and a novel technique used in healthcare to alleviate pain and provide patient comfort. It enables individuals to interact with a 360-degree virtual environment through a headset device. It has been observed that painful or emotionally stressful stimuli from the external world are diminished within the VR environment, with the individual's attention redirected and focused on this immersive setting. In our study, a 20-minute VR video will be used, providing the sensation of walking through a calming 360-degree virtual forest environment accompanied by natural sounds, viewed through VR headsets. Unlike some commercially available VR headsets, the Oculus Quest 2 model will be utilized, as it serves as both the computer and display system, eliminating the need for a smartphone. This device is preferred for its ability to deliver high-quality video without interruptions that might negatively affect the VR experience. After explaining

Experimental: Virtual Forest Bathing

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Willingness to participate in the study
  • Ability to communicate verbally
  • Absence of any psychiatric disorder
  • Undergoing bariatric surgery
  • No prior experience with virtual forest bathing

You may not qualify if:

  • Inability to establish communication
  • Presence of major hearing or visual impairment
  • Presence of any condition that may affect decision-making ability (e.g., psychological disorders, dementia)
  • Use of medications that may affect cognitive status (e.g., sedatives, antipsychotics)
  • Patients who report having previously experienced virtual forest bathing will be excluded from the sample

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Muazzez Merve TORAMAN

    Atatürk Üniversity

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Muazzez Merve TORAMAN

CONTACT

Zeynep KARAMAN ÖZLÜ, Prof. Dr.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

August 10, 2025

First Posted

September 3, 2025

Study Start

August 25, 2025

Primary Completion

December 25, 2025

Study Completion (Estimated)

August 25, 2026

Last Updated

September 3, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share