Anxiety Clinical Trial
Official title:
The Effect of Stress Ball Intervention During Non-Stress Test on Anxiety and Fetal Well-Being in Women With High-risk Pregnancy: A Randomized Controlled Study
This research will be conducted to determine the effect of stress ball intervention during NST on anxiety and fetal well-being in high-risk pregnant women. Women with high-risk pregnancies randomly assigned to intervention (n=43) and control (n=43) groups at a state and a faculty hospital in Turkey will be included in the study. Pregnant women in the intervention group will be told to squeeze and release the ball once after counting to three, to inhale each time they press the ball, to exhale when they relax their grip and to focus only on the ball. Pregnant women will be instructed to continue this practice throughout the NST procedure (approximately 20 minutes). Pregnant women in the control group will not receive any intervention other than routine hospital care during the NST procedure. Data on anxiety and fetal well-being outcomes will be collected before and after NST.
Status | Not yet recruiting |
Enrollment | 86 |
Est. completion date | August 31, 2024 |
Est. primary completion date | August 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: - Volunteering to participate in the research, - Being over 18 years of age, - Having a medically diagnosed risky condition during pregnancy (diabetes, hypertension, the threat of premature birth, eclampsia, etc.) - Compliance with at least one of the criteria in the "Ministry of Health Pregnancy Risk Assessment Form" in the evaluation of "Current Pregnancy" (Table 1) - Being at or above the 32nd week of pregnancy, - Having a single living fetus, - Having eaten at least two hours before the NST procedure, - Not having smoked or consumed alcohol at least two hours before the NST procedure, - Knowing how to read and write Turkish. Exclusion Criteria: - Deceleration or uterine contraction during NST, - Presence of cardiovascular disease in the fetus, - Presence of fetal distress, - Presence of fetal anomaly, - According to the physician, urgent intervention is needed, - Having a diagnosed psychiatric disease, - Having a visual, hearing, speaking, physical or mental disability. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Hümeyra TÜLEK DENIZ |
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* Note: There are 21 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Anxiety | State-Trait Anxiety Inventory was developed by Spielberger et al. (1970), and the Turkish reliability and validity of the scale was conducted by Öner and Le Compte (1983). The scale consists of two subunits that measure anxiety separately: State Anxiety, the individual's anxiety at a particular moment and under certain conditions; Trait Anxiety, on the other hand, often requires describing how they feel. Only the state anxiety scale will be used in this study. The scale has 20 direct and reversed items, and each item is a 4-point Likert type. The total score from the scale varies between 20 and 80, with a higher score indicating a higher level of anxiety. Cronbach's alpha coefficient was 0.83 for State Anxiety (Öner and Le Compte, 1983). | Anxiety levels will be assessed 5 minutes before intervention and 5 minutes after the end of the intervention. | |
Secondary | Fetal well-being | This form was created based on the literature (Soylu et al., 2022; Baltaci and Baser, 2022). As the first outcome measure of the research, fetal heart rate will be recorded in this form. | The outcome measure included in this form will be evaluated 5 minutes before the intervention and 5 minutes after the end of the intervention. | |
Secondary | Fetal well-being | This form was created based on the literature (Soylu et al., 2022; Baltaci and Baser, 2022).
As the second outcome measure of the research, the number of fetal movements will be recorded in this form. |
The outcome measure included in this form will be evaluated 5 minutes before the intervention and 5 minutes after the end of the intervention. | |
Secondary | Fetal well-being | This form was created based on the literature (Soylu et al., 2022; Baltaci and Baser, 2022).
As the third outcome measure of the research, reactivity will be recorded in this form. |
The outcome measure included in this form will be evaluated 5 minutes before the intervention and 5 minutes after the end of the intervention. | |
Secondary | Fetal well-being | This form was created based on the literature (Soylu et al., 2022; Baltaci and Baser, 2022).
As the fourth outcome measure of the research, variability will be recorded in this form. |
The outcome measure included in this form will be evaluated 5 minutes before the intervention and 5 minutes after the end of the intervention. | |
Secondary | Fetal well-being | This form was created based on the literature (Soylu et al., 2022; Baltaci and Baser, 2022).
As the fifth outcome measure of the research, the number of accelerations will be recorded in this form. |
The outcome measure included in this form will be evaluated 5 minutes before the intervention and 5 minutes after the end of the intervention. |
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