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Completed

NCT Number: NCT05313373

The Effect of Virtual Reality on Women Undergoing Hysterosalpingography

The aim of this study is to determine the effect of virtual reality on perceived pain, anxiety, fear, physiological reactions and satisfaction in women during the HSG procedure.

Hypotheses H01; In the HSG procedure, there was no difference between the pain score of the virtual reality group and the pain score of the control group.

H02; In the HSG procedure, there was no difference between the anxiety score of the virtual reality group and the anxiety score of the control group.

H03; In the HSG procedure, there was no difference between the satisfaction score of the virtual reality group and the satisfaction score of the control group.

H04; In the HSG procedure, there was no difference between the vital signs of the virtual reality group and the control group.

H05; In the HSG procedure, there was no difference between the fear score of the virtual reality group and the fear score of the control group.

The study will be carried out in two different groups. The practice will start with meeting the women who apply to the Radiology clinic for an HSG. After the women are evaluated in terms of eligibility criteria for the research, the women who are eligible will be informed about the research and written informed consent will be obtained from the women who accept. The random distribution of women to the study groups will be carried out using the Block Randomization method. The following applications will be made to the groups.

Virtual Reality Group In addition to the routine procedure, virtual reality glasses will be applied to the women in the virtual reality group of the research. Virtual reality glasses is a device that works on compatible smart mobile phones. After being taken to the gynecological table for the HSG procedure, the women included in the experimental group will be made to watch a video lasting an average of 10 minutes with virtual reality glasses until the procedure is completed. While watching the video, the relaxing music of the video will be played in the practice room with a bluetooth speaker.

Control Group Patients in the control group of the study will not be subjected to any treatment other than the routine procedure.

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Key information

Conditions

Hysterosalpingography

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ankara University Fertility Diagnosis, Treatment, Research and Application Center, Ankara, Mamak, Turkey (Türkiye)

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • primary infertility
  • Agreeing to participate in the research and obtaining written permission,
  • No hearing or vision problems
  • The first time HSG procedure will be applied

Exclusion criteria

  • Didn't watch the whole video
  • Those with motion-sensitive diseases such as vertigo, meniere
  • Using any pharmacological pain-reducing method within 30 minutes
  • Difficulty in the HSG process or completing the process with more than one attempt
  • Use of antidepressants or sedatives
  • Any history of allergy to radio-opaque dye

Treatment and study plan

Virtual Reality

Other

In addition to the routine procedure, virtual reality glasses will be applied to the women in the virtual reality group of the research. Virtual reality glasses is a device that works on compatible smart mobile phones. After being taken to the gynecological table for the HSG procedure, the women included in the experimental group will be made to watch a video lasting an average of 10 minutes with virtual reality glasses until the procedure is completed. While watching the video, the relaxing music of the video will be played.

Primary outcomes

  1. Change in anxiety

    Time frame: immediately before the HSG procedure and immediately after the HSG procedure

    STAI-S consist of 20 items with four points Likert scales, each (not at all, somewhat, moderately so, very much so). Scores thus range between 20, indicating a low level of anxiety and 80, indicating a high level.

  2. Change in the degree of pain experienced during the procedure

    Time frame: immediately before the HSG procedure, and immediately after the HSG procedure, and 15 minutes after the HSG procedure

    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

  3. Change in fear

    Time frame: immediately before the HSG procedure, immediately after the HSG procedure, and 15 minutes after the HSG procedure

    VAS is a 10-cm-long measurement tool. The left end of the scale reads "no fear at all" and the right end reads "the most intense fear possible". A high score on the scale indicated a high level of fear and a score of 0 pointed to no fear.

Secondary outcomes

  1. the degree of satisfaction

    Time frame: 15 minutes after the HSG procedure

    VAS is a 10-cm-long measurement tool. The left end of the scale reads "I am not satisfied at all" and the right end reads "very satisfied". A high score on the scale indicated a high level of satisfied and a score of 0 pointed to no satisfied.

  2. Change in blood pressure

    Time frame: immediately before the HSG procedure, and immediately after the HSG procedure, and 15 minutes after the HSG procedure

    mmHg

  3. Change in heart rate

    Time frame: immediately before the HSG procedure, and immediately after the HSG procedure, and 15 minutes after the HSG procedure

    beats per minute (bpm)

  4. Change in body temperature

    Time frame: immediately before the HSG procedure, and immediately after the HSG procedure, and 15 minutes after the HSG procedure

    degrees Celsius

  5. Change in the saturation of peripheral oxygen SpO2

    Time frame: immediately before the HSG procedure, and immediately after the HSG procedure, and 15 minutes after the HSG procedure

  6. HSG result

    Time frame: 15 minutes after the HSG procedure

    both tubes patent, one fallopian tubes occluded, both fallopian tubes occluded

  7. contrast medium volume

    Time frame: during HSG prosedure

    milliliter (ml)

Sponsors and collaborators

Lead sponsor

NESLİHAN YILMAZ SEZER

Other

Registry information

Official study title

The Effect of Virtual Reality On Women's Perceptıons of Fear, Pain, Anxiety and Satisfaction Undergoing Hysterosalpingography; A Randomized Controlled Research

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 6, 2022
Registry last updated
Jan 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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