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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

Primary Purpose

Psychological Stress, Anxiety, Prenatal Attachment

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Watching videos with nature images accompanied by nature sounds with virtual reality glasses
Sponsored by
Selcuk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Psychological Stress focused on measuring Psychological Stress, Anxiety, Prenatal attachment, Pleasure, Virtual Reality, Preterm Birth

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Selcuk University Faculty of Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

watching video with virtual reality glasses

routine maintenance, no intervention

Arm Description

Outcomes

Primary Outcome Measures

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
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).
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).

Secondary Outcome Measures

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
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).
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
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.

Full Information

First Posted
April 23, 2022
Last Updated
September 25, 2022
Sponsor
Selcuk University
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1. Study Identification

Unique Protocol Identification Number
NCT05352503
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
April 5, 2022 (Actual)
Primary Completion Date
July 20, 2022 (Actual)
Study Completion Date
September 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Selcuk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychological Stress, Anxiety, Prenatal Attachment, Pleasure, Virtual Reality, Preterm Birth
Keywords
Psychological Stress, Anxiety, Prenatal attachment, Pleasure, Virtual Reality, Preterm Birth

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
watching video with virtual reality glasses
Arm Type
Experimental
Arm Title
routine maintenance, no intervention
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Watching videos with nature images accompanied by nature sounds with virtual reality glasses
Intervention Description
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.
Primary Outcome Measure Information:
Title
Depression Anxiety Stress Scale (DASS-21)
Description
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
Time Frame
first day
Title
State Anxiety Scale
Description
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).
Time Frame
first day
Title
The Prenatal Attachment Inventory
Description
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).
Time Frame
first day
Secondary Outcome Measure Information:
Title
Depression Anxiety Stress Scale (DASS-21)
Description
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
Time Frame
second day
Title
State Anxiety Scale
Description
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).
Time Frame
second day
Title
The Prenatal Attachment Inventory
Description
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
Time Frame
second day
Title
Virtual Reality Glasses (SGG) Application Satisfaction Level Information Form
Description
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.
Time Frame
second day

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Selcuk University Faculty of Health Sciences
City
Konya
ZIP/Postal Code
42130
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
31094789
Citation
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Results Reference
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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.
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24090740
Citation
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.
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PubMed Identifier
18177778
Citation
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.
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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.
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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.
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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.
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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.
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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.
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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

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