The Effect of Stress Ball Intervention During Non-Stress Test on Anxiety and Fetal Well-Being in High-Risk Pregnancy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorHümeyra TÜLEK DENİZ
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
Deceleration or uterine contraction during NST,
Presence of cardiovascular disease in the fetus,
Presence of fetal distress,
Presence of fetal anomaly,
Trial design
Design model
Parallel
Treatments tested in this trial
Stress Ball Intervention
BehavioralThe stress ball has a soft plastic or silicone structure that can be held comfortably. Each ball is approximately 6 cm in diameter, in different colors, and is a soft toy that can be squeezed and manipulated with fingers to relieve stress and muscle tension and exercise the muscles (Apaydin Cirik et al., 2023). Squeezing a stress ball is a distraction and relaxation method. It is thought that squeezing a stress ball may be advantageous for reducing anxiety, considering its reliability, easy accessibility, effectiveness, low cost, sustainability, non-pharmacological and non-invasive properties.
Treatment groups
86 Participants
are divided into 2 treatment groupsGroup A: Control GroupNo intervention 0 interventions
Group B: Intervention GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Anxiety
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.
Time frame
5 minutes before intervention and 5 minutes after the end of the intervention.Secondary outcomes
1
Fetal well-being
This form was created based on the literature. As the secondary outcome measure of the research, fetal well-being will be recorded in this form.
Time frame
5 minutes before the intervention and 5 minutes after the end of the intervention.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Hümeyra TÜLEK DENİZ
Lead sponsor
Kafkas University
Sponsor institution
Source ClinicalTrials.gov