Clinical trial NCT05192330: Intrauterine Insemination and Nursing
Official title: The Effect of Virtual Reality Glasses Use and Therapeutic Touch on Pain, Anxiety and Patient Satisfaction in Women During Intrauterine Insemination Procedure: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: intrauterine insemination
nursing
pain
anxiety
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2022-01-14
Enrollment: 96
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 will conduct at Ondokuz Mayis University Training and Research Hospital, Obstetrics and Gynecology polyclinic between January 2022 and June 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: This study investigates the effect of virtual reality glasses use and therapeutic touch on pain, anxiety and patient satisfaction in women during intrauterine insemination procedure

Detailed description: Infertility treatment is a stressful and anxious process that begins when couples are diagnosed with infertility. Infertility treatment is a process that requires the active participation of couples against emotional and physical difficulties. In addition to intensive routine and surgical procedures, the treatment process is a period in which couples should be in constant communication with healthcare professionals. In Turkey, it is estimated that 10-20% of the couples are diagnosed with infertility. In the evaluation of infertile couples,Intrauterine Insemination is a simple, safe, and minimally invasive procedure to the process of injecting washed sperm into the uterine cavity close to ovulation. Sperm cells taken from men are injected directly into the uterus and left at a point closer to the fertilization point. The aim of this study is to investigate the effect of virtual reality glasses use and therapeutic touch on pain, anxiety and patient satisfaction in women during intrauterine insemination procedure.

This randomized controlled study will conduct at Ondokuz Mayis University Training and Research Hospital, Infertility polyclinic between january 2022 and June 2022.

Volunteer women undergoing Intrauterine Insemination will be include. Participants will randomly assigned to the 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, duration of infertility, previous pregnancies, births, abortion/curettage numbers, Spielberger State Anxiety Scale and Visual Analog Scale scores will use for each patient. After obtaining written informed consent, the data collection form, Spielberger State Anxiety Scale and VAS scoring scale (pain and nursing satisfaction) were applied to both groups by face to face interview during the day giving appointment for Intrauterine Insemination. Immediately after the questionnaires will apply, the nurse gave virtual reality glasses. and glasses will be put on before the process starts and training will be given to continue watching the video while wearing the glasses for 30 minutes. Second group participants the nurse researcher will start the application by taking an appropriate hand of the patient between his hands and hold it for 30 minutes.

Participant in the control group received standard care (verbal information about procedure and a short written information about the procedure) and no intervention (virtual reality or therapeutic touch) was performed.The IBM SPSS (Statistical package for the Social Sciences) 23.0 package program was used to evaluate the data obtained in the study.

Eligibility criteria: Inclusion Criteria:

being diagnosed with infertility over 18 years, being able to understand, read and write in Turkish, wanting to participate in the study,

Exclusion Criteria:

not wanting to be included in the study not accepting Therapeutic Touch or Virtual reality glasses not knowing Turkish not wanting to be included in the study

Primary outcomes:
measure: Spielberger State Anxiety Scale
timeFrame: 30 minutes
measure: Visual Analog Scale for pain intensity
timeFrame: 10 minutes
measure: Visual Analog Scale for patient satifaction
timeFrame: 10 minutess
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: Neşe KARAKAYA, lecturer
role: STUDY_CHAIR
References:
citation: Nazarinasab, M., Motamedfar, A., Najafian, M., & Tabibi, H. (2018). Investigating the effects of relaxation therapy on decreasing anxiety in patients with elective caesarean section in Imam Khomeini Hospital, Ahvaz, Iran during 2016. Medical Studies/Studia Medyczne, 34(2), 107-111.