Clinical trial NCT06802692: Effects of Virtual Reality Glasses and Meditation Music on Anxiety, Pain, Vital Signs, Satisfaction and Pregnancy Outcomes in Embryo Transfer Procedure
Official title: Determination of the Effects of Virtual Reality Glasses and Meditation Music on Anxiety, Pain, Vital Signs, Satisfaction and Pregnancy Outcomes During Embryo Transfer Procedure: a Randomized Controlled Experimental Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Being Diagnosed with Primary Infertility
Having Had an Embryo Transfer for the First Time
Keywords: Embryo Transfer
Virtual Reality Glasses
Meditation Music
Anxiety
Pain
Vital Signs
Satisfaction
Pregnancy
Lead sponsor: Nuh Naci Yazgan University
Sponsor class: OTHER
First posted: 2025-01-31
Enrollment: 105
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: State-Trait Anxiety Scale
timeFrame: To be administered to women 15 minutes before the ET procedure and immediately after the ET procedure is completed (the ET procedure is 20 minutes). Change in baseline State-Trait Anxiety Scale scores at the end of 35 minutes.
measure: VAS-Pain
timeFrame: Applied to women immediately before the ET procedure and immediately after the ET procedure is completed (ET procedure is 20 minutes). Change in baseline VAS-Pain scores after 20 minutes.
measure: Change from Baseline Pulse Rates
timeFrame: Pulse will be measured 15 minutes before the ET procedure and on the same day immediately after the ET procedure is completed (ET procedure is 20 minutes). Change from baseline pulse rates after 35 minutes.
measure: Change from Baseline Blood Pressure
timeFrame: Blood pressure will be measured 15 minutes before the ET procedure and on the same day immediately after the ET procedure is completed (ET procedure is 20 minutes). Change from baseline blood pressure after 35 minutes.
measure: Change from Baseline Respiratory Rates
timeFrame: Respiratory rates will be measured 15 minutes before the ET procedure and on the same day immediately after the ET procedure is completed (ET procedure is 20 minutes). Change from respiratory rates after 35 minutes.
measure: Change from Baseline Oxygen Saturation (SpO2)
timeFrame: Oxygen saturation will be measured 15 minutes before the ET procedure and on the same day immediately after the ET procedure is completed (ET procedure is 20 minutes). Change from oxygen saturation after 35 minutes.
measure: VRG+meditation music group satisfaction form
timeFrame: This form must be filled out on the same day, 15 minutes after the ET process is completed.
measure: Meditation music group satisfaction form
timeFrame: This form must be filled out on the same day, 15 minutes after the ET process is completed.
measure: Control group ET process satisfaction form
timeFrame: This form must be filled out on the same day, 15 minutes after the ET process is completed.
Secondary outcomes:
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Nuh Naci Yazgan University
Study officials:
References:
citation: • Smith AC, Armour M, Shewamene Z, Tan HY, Norman RJ, Johnson NP (2019) Acupuncture performed around the time of embryo transfer: a systematic review and meta-analysis. RBMO; 38(3): 364-379. https://doi.org/10.1016/j.rbmo.2018.12.038 • Kızılkaya M, Karaahmet AY, Beydag KD (2024) The Effect of Music Interventions on Anxiety, Pain, and Pregnancy Rates in Women with Infertility Before Oocyte Collection and Embryo Transfer: Systematic Review and Meta analysis of Randomized Controlled Trials. European Journal of Integrative Medicine. 72. 102408. https://doi.org/10.1016/j.eujim.2024.10240 • Gu YE, Zhang X, Zhang Q, Dai MC, Wu Y, Zhou Y, Qu F (2019) The effects of acupuncture on pregnancy outcomes of in vitro fertilization with embryo transfer: An interdisciplinary systematic review. Journal of Gynecology Obstetrics Human Reproduction 48(8): 677-684. https://doi.org/10.1016/j.jogoh.2019.07.008 • Karaman Özlü Z, Yetiş Demir Z, Özlü İ, Kılınç T, Yayla A (2022) Cerrahi Hastalarında Müzik Terapinin Semptom Yönetimine Etkisi. Karya Journal Of Health Scıence. 3(3): 354-358. https://doi.org/10.52831/kjhs.1110926 • Federica Di Guardo & Marco Palumbo (2022) Immersive virtual reality as tool to reduce anxiety during embryo transfer. Journal of Obstetrics and Gynaecology. 42(5): 802-808, https://doi.org/10.1080/01443615.2021.1995855 • Saravelos SH, Wong AWY, Kong GWS, Huang J, Klitzman R, Li TC (2016) Pain duringembryotransfer isindependently associated with clinical pregnancy in fresh/frozen assisted reproductive technology cycles. The Journal of Obstetrics and Gynaecology Research, 42(6): 684-693. https://doi.org/10.1111/jog.12962 • Wewers M, Lowe N. A critical review of visual analogue scales in the measurement of clinical phenomena Research in nursing & health 1990;13:227-36. https://doi.org/10.1002/nur.4770130405 • Spielberger CD, Gorsuch RL and Lushene RE (1970) STAI Manual for the State-Trait Anxiety Inventory. Consulting Psychologists Press. • Oner N, Le Compte A. Duru