Effects of Virtual Reality Glasses and Meditation Music on Anxiety, Pain, Vital Signs, Satisfaction and Pregnancy Outcomes in Embryo Transfer Procedure

Nuh Naci Yazgan University

Status: Not yet enrolling

Conditions: Having Had an Embryo Transfer for the First Time; Being Diagnosed with Primary Infertility

Treatments: Behavioral: Meditation music group; Behavioral: VR glasses and meditation music group

Study type: Interventional

Funder types: Other

Identifiers

NCT06802692

Nuh Naci Yazgan University (Other Identifier)

NuhNaciYazganUdk

Details and patient eligibility

About

The aim of this study is to determine the effects of virtual reality glasses (VRG) and meditation music on anxiety, pain, vital signs, satisfaction and pregnancy outcomes during the embryo transfer (ET) procedure.

H1: VR glasses + meditation music (1st intervention group), meditation music (2nd intervention group) application has an effect on anxiety.

H2: VR glasses + meditation music (1st intervention group), meditation music (2nd intervention group) application has an effect on pain.

H3: VR glasses + meditation music (1st intervention group), meditation music (2nd intervention group) application has an effect on vital signs (pulse rate, blood pressure, respiration).

H4: VR glasses + meditation music (1st intervention group), meditation music (2nd intervention group) application has an effect on patient satisfaction.

H5: VR glasses + meditation music (1st intervention group), meditation music (2nd intervention group) application has an effect on pregnancy outcomes.

35 women will be included in the VRG+meditation group, 35 women in the meditation group, and 35 women in the control group. The first group will be shown a nature view with VRG and will listen to meditation music 15 minutes before the ET. The second group will be shown meditation music 15 minutes before the embryo transfer. No intervention will be made in the third group. In the first two groups, anxiety, pain, vital signs (pulse, diastolic blood pressure, systolic blood pressure, respiration, and peripheral oxygen saturation) will be assessed 15 minutes before and immediately after the ET procedure. In the first group, satisfaction with the ET procedure, VRG application, and listening to meditation music will be assessed 15 minutes after the ET procedure. In the second group, satisfaction with the ET procedure and listening to meditation music will be assessed 15 minutes after the ET procedure.

Full description

Infertility is considered not only financially costly and psychologically stressful, but also emotionally and physically painful due to the uncertainty of diagnostic and treatment procedures as well as pregnancy outcomes (Kızılkaya et al. 2024). In vitro fertilization (IVF-ET) with embryo transfer is an effective treatment for infertility worldwide (Gu et al 2019). Embryo transfer (ET), being the final and critical step of the IVF cycle, can often cause anxiety and pain in couples (Federica Di Guardo & Marco Palumbo 2022; Saravelos et al. 2016). Women are likely to experience anxiety and depression at the end of long and uncertain treatment processes (Federica Di Guardo & Marco Palumbo 2022). The patient's bladder should be full before the ET procedure. This can help both to visualize the uterus more clearly on ultrasound and to facilitate the passage of the transfer catheter by correcting the anteverted uterus. However, patients complain of significant discomfort and pain due to their full bladder, especially when the ultrasound probe is pressed against the abdomen (Frishman et al 2007). Pain can also be caused by passing the catheter through the cervix (Karavani et al. 2017).

Women seek information and treatment about complementary health approaches to increase their chances of conceiving, having a live birth, improving their health, quality of life, and reducing anxiety during treatment (Smith et al. 2019). In recent years, the use of complementary and alternative medicine has increased significantly because it is cost-effective, easy to access, and individuals do not have to worry about invasive procedures or side effects of chemical drugs. Virtual reality (VR) headset is defined as a computer-generated three-dimensional space in which the user is immersed. Its purpose is to provide users with the perception of being in a non-physical world and to create a sense of immersion by using head-mounted displays (HMDs) that surround them with images, sounds, or other stimuli. Intuitively, VR helps relieve symptoms of pain, stress, anxiety, and depression in an imaginary space and enables patients to achieve positive and pleasant emotions (Federica Di Guardo & Marco Palumbo 2022).

Listening to relaxing music before a stressful event affects the endocrine, autonomic, cognitive and emotional systems differently, and music-based interventions have low economic costs (Kızılkaya et al. 2024). Since music increases serotonin secretion, it makes people feel positive, reduces patient stress, increases comfort and helps them cope better with pain (Kızılkaya et al. 2024; Karaman Özlü et al. 2022). The benefits of music therapy include distracting, reducing anxiety and worry, providing pain control, reducing stress, facilitating communication, relaxing and eliminating insomnia, regulating vital signs, reducing sweating, relaxing muscles, providing easy breathing and strengthening the immune system (Karaman Özlü et al. 2022). Recent studies focusing on the relationship between psychological symptoms and pregnancy rates during Assisted Reproductive Technologies cycles have shown controversial results. Some authors have reported that the higher the stress level experienced by women before and during treatment, the lower the pregnancy rate (Klonoff-Cohen et al. 2001; An et al. 2013, Terzioğlu et al. 2016; Xu et al. 2017), while other studies have not supported the same results (Boivin et al. 2011; Pasch et al. 2012). Up to now, virtual reality and music listening applications have been used in different fields to determine pain, anxiety, vital signs and satisfaction, as well as in the field of women's health. However, very few studies have been found to reduce pain and anxiety experienced during the ET procedure. This study is the first randomized controlled trial known in the literature to investigate the effects of VR and meditation music, which are distraction methods during the embryo transfer procedure, on the anxiety, pain, vital signs, patient satisfaction and pregnancy outcomes of infertile women.

Enrollment: 105 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Being diagnosed with primary infertility
• Having had an embryo transfer for the first time

Exclusion criteria

• Using antidepressants or sedatives
• Using painkillers within 24 hours before the procedure
• Having hearing and vision impairment

Termination Criteria:

• Removing glasses during the procedure
• Removing headphones during the procedure

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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105 participants in 3 patient groups

Visual reality glasses and meditation music group

Experimental group

Description:

Starting 15 minutes before the ET procedure, participants in the VR glasses and meditation music group will be shown a video of the sea, underwater and forest with VR glasses and will be made to listen to meditation music. At the same time, meditation music will be played. When the ET procedure is completed, the video and meditation music will be stopped. After the procedure, the VR glasses will be disinfected with antiseptic spray before being used on another patient, and disposable ear pads will be placed on the headphones after each patient. Anxiety, pain, vital signs (pulse, diastolic blood pressure, systolic blood pressure, respiration and peripheral oxygen saturation) will be evaluated 15 minutes before and immediately after the ET procedure. 15 minutes after the ET procedure, satisfaction with the ET procedure, the application of VR glasses and listening to meditation music will be evaluated.

Treatment:

Behavioral: VR glasses and meditation music group

Meditation music group

Experimental group

Description:

Meditation music group participants will listen to meditation music through headphones starting from 15 minutes before the ET procedure until the procedure is completed. When the ET procedure is completed, the meditation music will be stopped. After the procedure, disposable ear pads will be placed on the headphones for each patient. Anxiety, pain, vital signs (pulse, diastolic blood pressure, systolic blood pressure, respiration and peripheral oxygen saturation) will be assessed 15 minutes before and immediately after the ET procedure. 15 minutes after the ET procedure, satisfaction with the ET procedure and listening to meditation music will be assessed.

Treatment:

Behavioral: Meditation music group

Control group

No Intervention group

Description:

Control group participants will not receive any intervention other than the ET procedure. Anxiety, pain, vital signs (pulse, diastolic blood pressure, systolic blood pressure, respiration, and peripheral oxygen saturation) will be assessed 15 minutes before and immediately after the ET procedure.