Clinical trial NCT05192343: Effects of Virtual Reality and Nature Sounds on Pain and Anxiety During Hysterosalpingography
Official title: Effects of Virtual Reality and Nature Sounds on Pain and Anxiety During Hysterosalpingography: Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Women's Health
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2022-01-14
Enrollment: 135
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

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,

Primary outcomes:
measure: Spielberger State Anxiety Scale
timeFrame: 30 minutes
measure: Visual Analog Scale For Satisfaction
timeFrame: 10 minutes
measure: Visual Analog Scale for pain
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Ondokuz Mayis University
state: Atakum
Study officials:
affiliation: Ondokuz Mayıs University
name: Emine KOÇ, Asst.Prof
role: STUDY_CHAIR
affiliation: Ondokuz Mayıs University
name: Nazlı BALTACI, Asst.Prof
role: STUDY_DIRECTOR
affiliation: Ondokuz Mayıs University
name: Elif KETEN EDİS, Lecturer
role: STUDY_CHAIR
References:
citation: Agwu, K. K., & Okoye, I. J. (2007). The effect of music on the anxiety levels of patients undergoing hysterosalpingography. Radiography, 13(2), 122-125.