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

September 25, 2022 updated by: Sureyya Kilic, Selcuk University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

126

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Konya, Turkey, 42130
        • Selcuk University Faculty of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: watching video with virtual reality glasses
Device: 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.
No Intervention: routine maintenance, no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
first day
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).
first day
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).
first day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression Anxiety Stress Scale (DASS-21)
Time Frame: second 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
second day
State Anxiety Scale
Time Frame: second 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).
second day
The Prenatal Attachment Inventory
Time Frame: second 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
second day
Virtual Reality Glasses (SGG) Application Satisfaction Level Information Form
Time Frame: second day
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.
second day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Selcuk University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 5, 2022

Primary Completion (Actual)

July 20, 2022

Study Completion (Actual)

September 25, 2022

Study Registration Dates

First Submitted

April 23, 2022

First Submitted That Met QC Criteria

April 23, 2022

First Posted (Actual)

April 28, 2022

Study Record Updates

Last Update Posted (Actual)

September 27, 2022

Last Update Submitted That Met QC Criteria

September 25, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SU12345

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Supporting Information Type

  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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