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

NCT ID: NCT05192343

Last Updated: 2023-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 135 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-07
• Study Completion Date: 2022-08-15

Brief Summary

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

Detailed Description

Infertility treatment is a stressful and anxious process that begins when couples are diagnosed with infertility. Although this process may seem like a simple medical intervention, the treatment stages affect the couple in many ways when it is deepened. Infertility treatment is a process that requires the active participation of couples against emotional and physical difficulties. The treatment process is a period in which couples should be in constant communication with healthcare professionals, as well as intensive routine and surgical procedures.In this process, medical and surgical treatment methods are used. In the literature, it is stated that 85-90% of the problems that cause infertility are solved with medical and surgical treatment. In the evaluation of infertile couples, hysterosalpingography (HSG) is a invasive radiologic procedure to visualize uterine cavity and tubes after contrast enhancement. HSG plays an important diagnostic role in finding the cause of infertility and in deciding the line of management.The aim of this study is to demonstrate the effects of virtual reality and nature sounds on pain and anxiety during hysterosalpingography. This randomized controlled study will conduct at Ondokuz Mayıs University Training and Research Hospital, Obstetrics and Gynecology polyclinic between February 2022 and August 2022. Volunteer women undergoing HSG as part of infertility evaluation will be includ. Participants will randomly assigned to the Virtual Reality and nature sounds intervention, nature sounds intervention or the control group using a computer-generated list. A data collection form including socio-demographic and obstetric characteristics such as age, educational status, place to live, duration of infertility, previous pregnancies, births, abortion/curettage numbers, Spielberger State Anxiety Scale and Visual Analog Scale for pain and Visual Analog Scales for satisfaction will use for each patient. After obtaining written informed consent, the data collection form, Spielberger State Anxiety Scale and VAS pain scoring scale will be applied to both groups by face to face interview during the day giving appointment for HSG. Immediately after the questionnaires were applied, the nurse gave virtual reality glasses and headphone to intervention group for before HSG and while HSG totally 30 minutes. The nurse gave to nature sounds intervention group headphone. After the groups will formed, a nature-based sound will listen to the women in the nature sounds group before and during the HSG procedure. 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. Participants in the control group received standard care (verbal information about procedure and a short written information about the procedure) and no intervention (nature sounds or virtual reality) will perform.The IBM SPSS (Statistical package for the Social Sciences) 23.0 package program will use to evaluate the data obtained in the study.

Conditions

Women's Health

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Virtual Reality and nature sounds

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.

Group Type: EXPERIMENTAL

Virtual Reality and nature sounds

Intervention Type: 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.

nature sounds

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.

Group Type: EXPERIMENTAL

nature sounds

Intervention Type: 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.

control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Virtual Reality and nature sounds

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.

Intervention Type: DEVICE

nature sounds

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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,

Exclusion Criteria

• 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,

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Sümeyye BAL

OTHER

Sponsor Role: lead

Responsible Party

Sümeyye BAL

Lecturer Dr.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Emine KOÇ, Asst.Prof

Role: STUDY_CHAIR

Ondokuz Mayıs University

Nazlı BALTACI, Asst.Prof

Role: STUDY_DIRECTOR

Ondokuz Mayıs University

Elif KETEN EDİS, Lecturer

Role: STUDY_CHAIR

Ondokuz Mayıs University

Locations

Ondokuz Mayis University

Samsun, Atakum, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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

Reference Type: BACKGROUND

Other Identifiers

2021/435

Identifier Type: -

Identifier Source: org_study_id