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NCT Number: NCT05352503

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

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.

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Key information

Conditions

Psychological Stress Anxiety Anxiety Disorders Behavior Behavioral Symptoms Female Urogenital Diseases and Pregnancy Complications Mental Disorders Obstetric Labor Complications Obstetric Labor, Premature Pleasure Pregnancy Complications Premature Birth Prenatal Attachment Preterm Birth Stress, Psychological Urogenital Diseases Virtual Reality

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Selcuk University Faculty of Health Sciences

Konya, 42130, Turkey (Türkiye)

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. 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

Primary outcomes

  1. 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

  2. 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).

  3. 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).

Secondary outcomes

  1. 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

  2. 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).

  3. 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

  4. 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.

Sponsors and collaborators

Lead sponsor

Selcuk University

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 28, 2022
Registry last updated
Sep 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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