Intrauterine Insemination and Nursing

NCT05192330 | Completed

• 1 other identifier: 2021/350
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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

Conditions

Infertility

Keywords

intrauterine insemination; nursing; pain; anxiety

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (3)

Virtual Reality Glasses

EXPERIMENTAL

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.

Device: Virtual Reality Glasses

Therapeutic Touch

EXPERIMENTAL

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.

Behavioral: Therapeutic Touch

control group

NO INTERVENTION

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.

Interventions

Virtual Reality Glasses 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.

Virtual Reality Glasses

Therapeutic Touch 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.

Therapeutic Touch

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Ondokuz Mayis University

Samsun, Atakum, 55200, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  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.

  PMID: 40148795 DERIVED

MeSH Terms

Conditions

Infertility; Pain; Anxiety Disorders

Interventions

Therapeutic Touch

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies

Study Officials

• Emine KOÇ, Asst.Prof

  Ondokuz Mayıs University

  STUDY CHAIR

• Neşe KARAKAYA, lecturer

  Ondokuz Mayıs University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: 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.

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: January 14, 2022
• Study Start: January 24, 2022
• Primary Completion: May 1, 2022
• Study Completion: June 1, 2022
• Last Updated: October 10, 2023

Record last verified: 2023-10

Locations

TU (1)