Intrauterine Insemination and Nursing

Infertility Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05192330
• Other study ID #: 2021/350
• Status: Completed
• Phase: N/A
• Start date: January 24, 2022
• Est. completion date: June 1, 2022

Study information

• Verified date: October 2023
• Source: Ondokuz Mayis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: June 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

Device:
• Virtual Reality Glasses
After obtaining informed consent, the data collection form, Spielberger State Anxiety Scale and VAS scoring scale (pain) were applied to both groups by face to face interview during the day giving appointment for intrauterine insemination. Immediately after the questionnaires were answered, virtual reality glasses were given by the nurse researcher to intervention group for 30 minutes.

Behavioral:
• Therapeutic Touch
After obtaining informed consent, the data collection form, Spielberger State Anxiety Scale and VAS (pain) scoring scale were applied to both groups by face to face interview during the day giving appointment for intrauterine insemination. Immediately after the questionnaires were answered, therapeutictouch were given by the nurse researcher to intervention group for 30 minutes.

Locations

Country	Name	City	State
Turkey	Ondokuz Mayis University	Samsun	Atakum

Sponsors (1)

Lead Sponsor	Collaborator
Ondokuz Mayis University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spielberger State Anxiety Scale	After completing the Intrauterine Insemination Procedure, participants filled out the 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.	30 minutes
Primary	Visual Analog Scale for pain intensity	After completing the Intrauterine Insemination Procedure, participants were asked to evaluate their pain in order to characterize pain intensity using the Visual Analog Scale (VAS).; A standard ten-point visual analogue scale (VAS) of 0 to 10 was designed and used to assess the patients' perceptions of discomfort during the procedure. A high score on the scale indicated a high level of discomfort and a score of 0 denoted no discomfort at all. Patients indicate the degree of pain they feel between 0-10.	10 minutes
Primary	Visual Analog Scale for patient satifaction	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 minutess