Intrauterine Insemination and Nursing

NCT ID: NCT05192330

Last Updated: 2023-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-24
• Study Completion Date: 2022-06-01

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.

Conditions

Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Virtual Reality Glasses

After obtaining written informed consent, the data collection form, Spielberger State Anxiety Scale and visual analogue scale(pain and nursing satisfaction) scoring scale will apply to both groups by face to face interview during the day giving appointment for intrauterine insemination. Immediately after the questionnaires were applied, the nurse gave Virtual Reality Glasses for 30 minutes.

Glasses will be given put on before the process starts and training will be given to continue watching the video while wearing the glasses.The women include in the Virtual reality application group will be shown a video with a nature view during the procedure.

Every woman will be shown the same video.

Group Type: EXPERIMENTAL

Virtual Reality Glasses

Intervention Type: DEVICE

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.

Therapeutic Touch

Applied therapeutic touch intervention on their hands for 30 minutes to help patients feel comfortable during the procedure.The researcher started the application by taking an appropriate hand of the patient between his hands and held it for 30 minutes. The researcher's fingers are closed, not clasped, and his hand is placed on the participant's hand.

The researcher held her hand steady without touching or rubbing it. In addition, the researcher is not use gloves.

Group Type: EXPERIMENTAL

Therapeutic Touch

Intervention Type: BEHAVIORAL

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.

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 (virtual reality or Therapeutic Touch) was performed. Both groups were re-evaluated using the same scales after the intrauterine insemination. Within 5 minutes of completing the procedure, participants will asked to evaluate their pain in order to characterize pain intensity using the visual analogue scale, anxiety scale and satisfaction scale.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: BEHAVIORAL

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

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

Sponsors

Ondokuz Mayıs University

OTHER

Sponsor Role: lead

Responsible Party

Sümeyye BAL

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emine KOÇ, Asst.Prof

Role: STUDY_CHAIR

Ondokuz Mayıs University

Neşe KARAKAYA, lecturer

Role: STUDY_CHAIR

Ondokuz Mayıs University

Locations

Ondokuz Mayis University

Samsun, Atakum, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

Bal S, Karakaya N, Koc E, Guven D. The effect of virtual reality (VR) glasses and therapeutic touch (TT) on pain, anxiety, and patient satisfaction during intrauterine insemination (IUI) compared to standard care: a single-blind, randomized controlled trial. BMC Pregnancy Childbirth. 2025 Mar 27;25(1):361. doi: 10.1186/s12884-025-07435-0.

Reference Type: DERIVED

PMID: 40148795 (View on PubMed)

Other Identifiers

2021/350

Identifier Type: -

Identifier Source: org_study_id