Psychological StressNCT05352503
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
A study testing Watching videos with nature images accompanied by nature sounds with virtual reality glasses in people with Psychological Stress and Anxiety, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Psychological Stress, Anxiety, Prenatal Attachment
- What is being tested?
- Watching videos with nature images accompanied by nature sounds with virtual reality glasses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Apr 2022to 25 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
Show all 9Show fewer
- Single pregnancy,
- Open to communication, spiritually and mentally healthy,
- Pregnant women who are married and living with their spouses.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Selcuk University Faculty of Health Sciences
Konya, 42130
About this study
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.
Read the detailed description
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
- Psychological Stress, Anxiety, Prenatal Attachment, Pleasure, Virtual Reality, Preterm Birth
- Being tested
- Watching videos with nature images accompanied by nature sounds with virtual reality glasses
- Keywords
- Psychological Stress, Anxiety, Prenatal attachment, Pleasure, Virtual Reality, Preterm Birth
- Medical subject headings
- Stress, Psychological, Anxiety Disorders, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Watching videos with nature images accompanied by nature sounds with virtual reality glassesDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| watching video with virtual reality glasses | Experimental | Not described Receives: Device: Watching videos with nature images accompanied by nature sounds with virtual reality glasses |
| routine maintenance, no intervention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression Anxiety Stress Scale (DASS-21)
Depression Anxiety Stress Scale (DASS-21); It was created as an abbreviation of DASS-42 developed by Lovibond and Lovibond (1995) (Lovibond and Lovibond 1995). The Turkish validity and reliability study of the scale was conducted by Sarıçam in 2018. Scale "Depression (3rd, 5th, 10th, 13th, 16th, 17th, 21st)", "Anxiety (2nd, 4th, 7th, 9th, 15th, 19th, 20.)" and "Stress (1st, 6th, 8th, 11th, 12th, 14th, 18th)" and 21 questions. Items in the scale; 4-point Likert-type scoring ranging from ''(0) never', ''(1) sometimes and sometimes'', ''(2) quite often'' and ''(3) always'' evaluated over. A minimum of 0 and a maximum of 21 points can be obtained from each sub-dimension. The higher the score, the higher the level of depression, anxiety and stress (Sarıçam 2018). In this study, the 'stress sub-dimension' of the DASS-21 scale will be used
Measured: first day
State Anxiety Scale
It was developed by Spielberger et al. in 1970 (Spielberger et al. 1970). Its adaptation to Turkish society, validity and reliability were done by Öner and Le Compte in 1985. The State Anxiety Scale consists of 20 items. The items expressing the emotions and behaviors in the scales vary in 4 levels as "(1) Not at all", "(2) A little", "(3) A lot" and "(4) Completely". It is evaluated on a 5-point Likert-type scoring system. A high score indicates a high level of anxiety. A score of six or less indicates no anxiety, 37-42 indicates mild anxiety, and a score of 43 and above indicates high anxiety (Öner and Le Compte 1985).
Measured: first day
The Prenatal Attachment Inventory
Prenatal Attachment Inventory; It is a 21-item scale developed by Mary Muller in 1993 to explain the feelings, thoughts and situations experienced by women during pregnancy and to determine the level of attachment to the fetus during the prenatal period (Muller 1993). The Turkish validity and reliability study of the scale was carried out by Yılmaz and Beji in 2009. Participants scored each item on a 4-point Likert-type rating scale as "(1) Never", "(2) Sometimes", "(3) Often", "(4) Always". evaluates over. A minimum of 21 and a maximum of 84 points can be obtained from the scale. As the score obtained by the pregnant increases, the level of attachment increases. The applicability of the scale for pregnant women at 20 weeks of gestation and above was found to be reliable and valid. Yılmaz and Beji found the Cronbach's alpha reliability coefficient as 0.84 in the internal consistency analysis of the scale (Yılmaz and Beji 3013).
Measured: first day
Secondary outcomes (4)
Depression Anxiety Stress Scale (DASS-21)
Depression Anxiety Stress Scale (DASS-21); It was created as an abbreviation of DASS-42 developed by Lovibond and Lovibond (1995) (Lovibond and Lovibond 1995). The Turkish validity and reliability study of the scale was conducted by Sarıçam in 2018. Scale "Depression (3rd, 5th, 10th, 13th, 16th, 17th, 21st)", "Anxiety (2nd, 4th, 7th, 9th, 15th, 19th, 20.)" and "Stress (1st, 6th, 8th, 11th, 12th, 14th, 18th)" and 21 questions. Items in the scale; 4-point Likert-type scoring ranging from ''(0) never', ''(1) sometimes and sometimes'', ''(2) quite often'' and ''(3) always'' evaluated over. A minimum of 0 and a maximum of 21 points can be obtained from each sub-dimension. The higher the score, the higher the level of depression, anxiety and stress (Sarıçam 2018). In this study, the 'stress sub-dimension' of the DASS-21 scale will be used
Measured: second day
State Anxiety Scale
It was developed by Spielberger et al. in 1970 (Spielberger et al. 1970). Its adaptation to Turkish society, validity and reliability were done by Öner and Le Compte in 1985. The State Anxiety Scale consists of 20 items. The items expressing the emotions and behaviors in the scales vary in 4 levels as "(1) Not at all", "(2) A little", "(3) A lot" and "(4) Completely". It is evaluated on a 5-point Likert-type scoring system. A high score indicates a high level of anxiety. A score of six or less indicates no anxiety, 37-42 indicates mild anxiety, and a score of 43 and above indicates high anxiety (Öner and Le Compte 1985).
Measured: second day
The Prenatal Attachment Inventory
Prenatal Attachment Inventory; It is a 21-item scale developed by Mary Muller in 1993 to explain the feelings, thoughts and situations experienced by women during pregnancy and to determine the level of attachment to the fetus during the prenatal period (Muller 1993). The Turkish validity and reliability study of the scale was carried out by Yılmaz and Beji in 2009. Participants scored each item on a 4-point Likert-type rating scale as "(1) Never", "(2) Sometimes", "(3) Often", "(4) Always". evaluates over. A minimum of 21 and a maximum of 84 points can be obtained from the scale. As the score obtained by the pregnant increases, the level of attachment increases. The applicability of the scale for pregnant women at 20 weeks of gestation and above was found to be reliable and valid. Yılmaz and Beji found the Cronbach's alpha reliability coefficient as 0.84 in the internal consistency analysis of the scale (Yılmaz and Beji 3013
Measured: second day
Virtual Reality Glasses (SGG) Application Satisfaction Level Information Form
This form was prepared by the researchers to determine the level of satisfaction of the pregnant women in the intervention group from the video watched with virtual reality glasses.
Measured: second day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start5 Apr 2022
- Primary completion20 Jul 2022
- Study completion25 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Psychological StressStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sureyya Kilic, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05352503
- Sponsor's protocol ID
- SU12345
- Status last verified
- Sep 2022
- First submitted
- 23 Apr 2022
- Last updated
- 27 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 31094789Garcia-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.
PubMed 28558282Glover 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.
PubMed 24090740Goldenberg 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.
PubMed 18177778Grigoriadis 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.
PubMed 30192449Gur 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.
PubMed 33478718Hajesmaeel-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.
PubMed 33765969Hoyer 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.
PubMed 32220767Lilliecreutz 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.
PubMed 26772181Kilic 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.
PubMed 37408298
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05352503
- Acronym / sponsor ID
- SU12345
- Conditions
- Psychological Stress, Anxiety, Prenatal Attachment, Pleasure, Virtual Reality, Preterm Birth
- Keywords
- Psychological Stress, Anxiety, Prenatal attachment, Pleasure, Virtual Reality, Preterm Birth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 5 Apr 2022 (actual)
- Primary completion
- 20 Jul 2022 (actual)
- Study completion
- 25 Sep 2022 (actual)
- First posted
- 28 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| watching video with virtual reality glasses | Experimental | Device: Watching videos with nature images accompanied by nature sounds with virtual reality glasses |
| routine maintenance, no intervention | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Watching videos with nature images accompanied by nature sounds with virtual reality glassesThe 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. | Device | watching video with virtual reality glasses |
Primary outcome
Depression Anxiety Stress Scale (DASS-21)
Time frame: first day
Depression Anxiety Stress Scale (DASS-21); It was created as an abbreviation of DASS-42 developed by Lovibond and Lovibond (1995) (Lovibond and Lovibond 1995). The Turkish validity and reliability study of the scale was conducted by Sarıçam in 2018. Scale "Depression (3rd, 5th, 10th, 13th, 16th, 17th, 21st)", "Anxiety (2nd, 4th, 7th, 9th, 15th, 19th, 20.)" and "Stress (1st, 6th, 8th, 11th, 12th, 14th, 18th)" and 21 questions. Items in the scale; 4-point Likert-type scoring ranging from ''(0) never', ''(1) sometimes and sometimes'', ''(2) quite often'' and ''(3) always'' evaluated over. A minimum of 0 and a maximum of 21 points can be obtained from each sub-dimension. The higher the score, the higher the level of depression, anxiety and stress (Sarıçam 2018). In this study, the 'stress sub-dimension' of the DASS-21 scale will be used
State Anxiety Scale
Time frame: first day
It was developed by Spielberger et al. in 1970 (Spielberger et al. 1970). Its adaptation to Turkish society, validity and reliability were done by Öner and Le Compte in 1985. The State Anxiety Scale consists of 20 items. The items expressing the emotions and behaviors in the scales vary in 4 levels as "(1) Not at all", "(2) A little", "(3) A lot" and "(4) Completely". It is evaluated on a 5-point Likert-type scoring system. A high score indicates a high level of anxiety. A score of six or less indicates no anxiety, 37-42 indicates mild anxiety, and a score of 43 and above indicates high anxiety (Öner and Le Compte 1985).
The Prenatal Attachment Inventory
Time frame: first day
Prenatal Attachment Inventory; It is a 21-item scale developed by Mary Muller in 1993 to explain the feelings, thoughts and situations experienced by women during pregnancy and to determine the level of attachment to the fetus during the prenatal period (Muller 1993). The Turkish validity and reliability study of the scale was carried out by Yılmaz and Beji in 2009. Participants scored each item on a 4-point Likert-type rating scale as "(1) Never", "(2) Sometimes", "(3) Often", "(4) Always". evaluates over. A minimum of 21 and a maximum of 84 points can be obtained from the scale. As the score obtained by the pregnant increases, the level of attachment increases. The applicability of the scale for pregnant women at 20 weeks of gestation and above was found to be reliable and valid. Yılmaz and Beji found the Cronbach's alpha reliability coefficient as 0.84 in the internal consistency analysis of the scale (Yılmaz and Beji 3013).
4 secondary outcomes
Depression Anxiety Stress Scale (DASS-21)
Time frame: second day
State Anxiety Scale
Time frame: second day
The Prenatal Attachment Inventory
Time frame: second day
Virtual Reality Glasses (SGG) Application Satisfaction Level Information Form
Time frame: second day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2022.
- Background: PubMed 31094789Frey 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.
- Background: PubMed 28558282Garcia-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.
- Background: PubMed 24090740Glover 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.
- Background: PubMed 18177778Goldenberg 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.
- Background: PubMed 30192449Grigoriadis 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.
- Background: PubMed 33478718Gur 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.
- Background: PubMed 33765969Hajesmaeel-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.
- Background: PubMed 32220767Hoyer 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.
- Background: PubMed 26772181Lilliecreutz 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.
- Derived from this study: PubMed 37408298Kilic 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Watching videos with nature images accompanied by nature sounds with virtual reality glasses in people with Psychological Stress and Anxiety, run by Selcuk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression Anxiety Stress Scale (DASS-21) (time frame: first day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05352503, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2022.