The Effects of Making Pregnant Women With Preterm Birth Threat Watch Nature Images With Virtual Reality Goggles on the Levels of Stress, Anxiety, Attachment, and Care Satisfaction

NCT ID: NCT05352503

Last Updated: 2022-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-05

Study Completion Date

2022-09-25

Brief Summary

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Virtual reality application, which is a non-pharmacological method, is used for different purposes in many different fields. One of the areas where virtual reality application is used is health services. Its use in the field of obstetrics is new. Virtual reality application is often in pregnancy; it is used to reduce pain, stress and anxiety levels, exercise training and train pregnant women to effectively manage their pain during childbirth. Although pregnancy is a normal physiological process, adverse situations may occur that can make every pregnancy risky. Threatened premature birth, which is called the onset of uterine contractions without cervical changes between the 20th and 37th weeks of pregnancy, is also among these risk groups. Pregnant women diagnosed with the threat of premature birth are usually treated by hospitalization. Psychological problems such as stress, fear and anxiety may develop in pregnant women who are on bed rest in the hospital. In these pregnant women, mother-infant attachment may also be adversely affected. Pregnant women who are hospitalized and taken to bed rest due to risky pregnancy need to be informed and supported by health personnel. The midwife's spending enough time with the pregnant woman, keeping in touch and meeting her needs increase satisfaction in terms of care. When the literature was examined, it was determined that pregnant women were satisfied with the virtual reality application and thus increased care satisfaction.

Detailed Description

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Virtual reality application, which is a non-pharmacological method, is used for different purposes in many different fields. One of the areas where virtual reality application is used is health services. Its use in the field of obstetrics is new. Virtual reality application is often in pregnancy; it is used to reduce pain, stress and anxiety levels, exercise training and train pregnant women to effectively manage their pain during childbirth. Although pregnancy is a normal physiological process, adverse situations may occur that can make every pregnancy risky. Threatened premature birth, which is called the onset of uterine contractions without cervical changes between the 20th and 37th weeks of pregnancy, is also among these risk groups. Pregnant women diagnosed with the threat of premature birth are usually treated by hospitalization. Psychological problems such as stress, fear and anxiety may develop in pregnant women who are on bed rest in the hospital. In these pregnant women, mother-infant attachment may also be adversely affected. Pregnant women who are hospitalized and taken to bed rest due to risky pregnancy need to be informed and supported by health personnel. The midwife's spending enough time with the pregnant woman, keeping in touch and meeting her needs increase satisfaction in terms of care. When the literature was examined, it was determined that pregnant women were satisfied with the virtual reality application and thus increased care satisfaction. In the literature, there is no study using virtual reality glasses in pregnant women diagnosed with preterm birth threat. For this reason, this study was planned to determine the effect of watching nature images with virtual reality glasses on the level of stress, anxiety, attachment and care satisfaction to pregnant women diagnosed with preterm birth threat.

Conditions

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Psychological Stress Anxiety Prenatal Attachment Pleasure Virtual Reality Preterm Birth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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watching video with virtual reality glasses

Group Type EXPERIMENTAL

Watching videos with nature images accompanied by nature sounds with virtual reality glasses

Intervention Type DEVICE

The video with nature images accompanied by the sounds of nature with virtual reality glasses will be watched 3 times a day for at least 5 minutes for 2 days.

routine maintenance, no intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Watching videos with nature images accompanied by nature sounds with virtual reality glasses

The video with nature images accompanied by the sounds of nature with virtual reality glasses will be watched 3 times a day for at least 5 minutes for 2 days.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* who are in the age group of 18 and over,
* Able to speak Turkish and express himself in Turkish,
* Not visually or hearing impaired,
* Diagnosed with the threat of premature birth,
* Between 24-37 weeks of gestation,
* Primiparous,
* Single pregnancy,
* Open to communication, spiritually and mentally healthy,
* Pregnant women who are married and living with their spouses.

Exclusion Criteria

* In addition to the diagnosis of threat of preterm birth, other diagnoses (preeclampsia, fetal distress, premature rupture of membranes, gestational diabetes, bleeding, etc.)
* Having a chronic disease
* Women who are pregnant by assisted reproductive techniques.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Selcuk University

OTHER

Sponsor Role lead

Responsible Party

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Sureyya Kilic

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Selcuk University Faculty of Health Sciences

Konya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Frey DP, Bauer ME, Bell CL, Low LK, Hassett AL, Cassidy RB, Boyer KD, Sharar SR. Virtual Reality Analgesia in Labor: The VRAIL Pilot Study-A Preliminary Randomized Controlled Trial Suggesting Benefit of Immersive Virtual Reality Analgesia in Unmedicated Laboring Women. Anesth Analg. 2019 Jun;128(6):e93-e96. doi: 10.1213/ANE.0000000000003649.

Reference Type BACKGROUND
PMID: 31094789 (View on PubMed)

Garcia-Blanco A, Diago V, Serrano De La Cruz V, Hervas D, Chafer-Pericas C, Vento M. Can stress biomarkers predict preterm birth in women with threatened preterm labor? Psychoneuroendocrinology. 2017 Sep;83:19-24. doi: 10.1016/j.psyneuen.2017.05.021. Epub 2017 May 25.

Reference Type BACKGROUND
PMID: 28558282 (View on PubMed)

Glover V. Maternal depression, anxiety and stress during pregnancy and child outcome; what needs to be done. Best Pract Res Clin Obstet Gynaecol. 2014 Jan;28(1):25-35. doi: 10.1016/j.bpobgyn.2013.08.017. Epub 2013 Sep 18.

Reference Type BACKGROUND
PMID: 24090740 (View on PubMed)

Goldenberg RL, Culhane JF, Iams JD, Romero R. Epidemiology and causes of preterm birth. Lancet. 2008 Jan 5;371(9606):75-84. doi: 10.1016/S0140-6736(08)60074-4.

Reference Type BACKGROUND
PMID: 18177778 (View on PubMed)

Grigoriadis S, Graves L, Peer M, Mamisashvili L, Tomlinson G, Vigod SN, Dennis CL, Steiner M, Brown C, Cheung A, Dawson H, Rector NA, Guenette M, Richter M. Maternal Anxiety During Pregnancy and the Association With Adverse Perinatal Outcomes: Systematic Review and Meta-Analysis. J Clin Psychiatry. 2018 Sep 4;79(5):17r12011. doi: 10.4088/JCP.17r12011.

Reference Type BACKGROUND
PMID: 30192449 (View on PubMed)

Gur EY, Apay SE. The effect of cognitive behavioral techniques using virtual reality on birth pain: a randomized controlled trial. Midwifery. 2020 Dec;91:102856. doi: 10.1016/j.midw.2020.102856. Epub 2020 Sep 28.

Reference Type BACKGROUND
PMID: 33478718 (View on PubMed)

Hajesmaeel-Gohari S, Sarpourian F, Shafiei E. Virtual reality applications to assist pregnant women: a scoping review. BMC Pregnancy Childbirth. 2021 Mar 25;21(1):249. doi: 10.1186/s12884-021-03725-5.

Reference Type BACKGROUND
PMID: 33765969 (View on PubMed)

Hoyer J, Wieder G, Hofler M, Krause L, Wittchen HU, Martini J. Do lifetime anxiety disorders (anxiety liability) and pregnancy-related anxiety predict complications during pregnancy and delivery? Early Hum Dev. 2020 May;144:105022. doi: 10.1016/j.earlhumdev.2020.105022. Epub 2020 Mar 25.

Reference Type BACKGROUND
PMID: 32220767 (View on PubMed)

Lilliecreutz C, Laren J, Sydsjo G, Josefsson A. Effect of maternal stress during pregnancy on the risk for preterm birth. BMC Pregnancy Childbirth. 2016 Jan 15;16:5. doi: 10.1186/s12884-015-0775-x.

Reference Type BACKGROUND
PMID: 26772181 (View on PubMed)

Kilic S, Dereli Yilmaz S. Virtual Reality Headset Simulating a Nature Environment to Improve Health Outcomes in Pregnant Women: A Randomized-Controlled Trial. Clin Nurs Res. 2023 Nov;32(8):1104-1114. doi: 10.1177/10547738231184923. Epub 2023 Jul 5.

Reference Type DERIVED
PMID: 37408298 (View on PubMed)

Other Identifiers

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SU12345

Identifier Type: -

Identifier Source: org_study_id

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