Effects of Virtual Reality and Nature Sounds on Pain and Anxiety During Hysterosalpingography

NCT05192343 | Completed

• 1 other identifier: 2021/435
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to demonstrate the effects of virtual reality and nature sounds on pain and anxiety during hysterosalpingography.

Conditions

Women's Health

Outcome Measures

Primary Outcomes (3)

• Spielberger State Anxiety Scale

  The inventory was developed by Spielberger, Gorsuch, and Lushene in 1970. An adaptation, validity, and reliability study of the State-Trait Anxiety Scale in Turkish was conducted by Oner and Le Compte in 1983. The scale consists of two subdimensions: the state anxiety has 20 items and is used to determine what is felt at a specific moment under certain conditions, and the trait anxiety has 20 items and is used to determine what has been felt in the last 7 days. High scores from each subscale indicate a high level of anxiety. The Cronbach's a for the STAI ranges from 0.83 to 0.87

  30 minutes

• Visual Analog Scale For Satisfaction

  Visual Analog Scale Satisfaction level was measured using the visual analog scale (VAS). VAS is used to convert some numerically unmeasured values to numeric values. VAS is a continuous scale that comprises a horizontal line or a vertical line, usually 10 cm (100 mm) in length. On one end of the scale is the statement, "I am not satisfied at all" (zero points), whereas the statement at the other end is "very satisfied." Patients were asked to mark their satisfaction levels on this scale of 100 mm.

  10 minutes

• Visual Analog Scale for pain

  The pain was assessed using 0-100 mm VAS for determining perceptions of pain during the procedure. This scale is widely used and has demonstrated reliability and validity in the measurement of acute pain. A high score on the scale indicated a high level of pain and a score of 0 pointed to no pain at all (Bijur, Silver, \& Gallagher, 2001). Each participant was asked to mark her current level of perceived pain along the scale, with the number corresponding to the marked point recorded as the pain score

  10 minutes

Study Arms (3)

Virtual Reality and nature sounds

EXPERIMENTAL

After obtaining written informed consent, the data collection form, Spielberger State Anxiety Scale and visual analogue scale scoring scale for pain will apply to both groups by face to face interview during the day giving appointment for hysterosalpingography. Immediately after the questionnaires will apply, before and during the HSG procedure, the Virtual Reality and nature sounds application group watch a video with a nature view with virtual reality glasses.Glasses will introduce before the procedure. Before the procedure started, glasses will put on and training will given to continue watching the video by wearing glasses during the procedure. The women will be included in the Virtual Reality and nature sounds intervention group will make to watch a video with a nature view for 15 minutes and listening nature sounds before and during the HSG procedure. Each woman was shown the same video.

Device: Virtual Reality and nature sounds

nature sounds

EXPERIMENTAL

After obtaining written informed consent, the data collection form, Spielberger State Anxiety Scale and visual analogue scale scoring scale for pain will apply to both groups by face to face interview during the day giving appointment for hysterosalpingography. Immediately after the questionnaires will apply, a nature-based sound will play to the women in the nature sounds group before and during the HSG shooting.Listening to nature-based sound will perform for a total of 15 minutes half an hour before the HSG procedure, and for 15 minutes during the procedure, for a total of 30 minutes.

Other: nature sounds

control group

NO INTERVENTION

Participants in the control group received standard care (verbal information about procedure and a short written information about the procedure) and no intervention will perform. Both groups will re-evaluated using the same scales after the hysterosalpingography.

Interventions

Virtual Reality and nature sounds DEVICE

After obtaining informed consent, the data collection form, Spielberger State Anxiety Scale and VAS scoring scale for pain were applied to both groups by face to face interview during the day giving appointment for HSG. Before and during the HSG shooting, the virtual reality and nature sounds application group watched a video with a nature view with virtual reality glasses and listening nature sounds. Glasses were introduced before the procedure. Before the procedure started, glasses were put on and training was given to continue watching the video by wearing glasses during the procedure. The women include in the virtual reality and nature sounds application group will make to watch a video with a nature view with nature sounds for 15 minutes before and during the HSG procedure. Each woman was shown the same video.

Virtual Reality and nature sounds

nature sounds OTHER

After obtaining informed consent, the data collection form, Spielberger State Anxiety Scale and VAS scoring scale for pain were applied to both groups by face to face interview during the day giving appointment for HSG. Before the procedure started, glasses will put on and training was given to continue. After the groups were formed, a nature-based sound was played to the women in the nature sounds group before and during the HSG shooting. Listening to nature-based sound will perform for a total of 15 minutes half an hour before the HSG procedure, and for 15 minutes during the procedure, for a total of 30 minutes.

nature sounds

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Wanting to participate in the study,
• being literate,
• over 18 years,
• at least primary school graduate,
• without a diagnosed psychiatric illness,
• not have mental insufficiency and communication problems,
• have no hearing problems,
• without drug sensitivity and allergy,

You may not qualify if:

• illiterate,
• with a diagnosed psychiatric illness,
• mental deficiency and communication problems,
• under 18 years old,
• who did not want to participate in the research,
• having hearing problems
• drug sensitivity and allergy,

Sponsors & Collaborators

• Sümeyye BAL: lead

Study Sites (1)

Ondokuz Mayis University

Samsun, Atakum, 55200, Turkey (Türkiye)

Location

Related Publications (1)

• Agwu, K. K., & Okoye, I. J. (2007). The effect of music on the anxiety levels of patients undergoing hysterosalpingography. Radiography, 13(2), 122-125.

  BACKGROUND

Study Officials

• Emine KOÇ, Asst.Prof

  Ondokuz Mayıs University

  STUDY CHAIR

• Nazlı BALTACI, Asst.Prof

  Ondokuz Mayıs University

  STUDY DIRECTOR

• Elif KETEN EDİS, Lecturer

  Ondokuz Mayıs University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer Dr.

Model Details: This randomized controlled study was conducted at Ondokuz Mayis University Training and Research Hospital, Obstetrics and Gynecology polyclinic between February 2022 and August 2022. The CONSORT (Consolidated Standards of Reporting Trials) guidelines for reporting randomised controlled trials (RCTs) has been used to describe the methods.

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: January 14, 2022
• Study Start: February 7, 2022
• Primary Completion: April 25, 2022
• Study Completion: August 15, 2022
• Last Updated: September 26, 2023

Record last verified: 2023-09

Locations

TU (1)