The Effect of Stress Ball Intervention During Non-Stress Test on Anxiety and Fetal Well-Being in High-Risk Pregnancy

NCT06302010 | Recruiting

• 1 other identifier: KafkasU3636
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anxiety; Fetal Conditions; Pregnancy Related

Keywords

anxiety; fetal well-being; high-risk pregnant women; Non stres test; stress ball; nurse

Outcome Measures

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.

  5 minutes before intervention and 5 minutes after the end of the intervention.

Secondary Outcomes (1)

• Fetal well-being

  5 minutes before the intervention and 5 minutes after the end of the intervention.

Study Arms (2)

Control Group

NO INTERVENTION

Pregnant women in the control group will not receive any intervention other than routine hospital care during the NST procedure.

Intervention Group

EXPERIMENTAL

Pregnant women in the intervention group will be explained how to use the stress ball before NST. Pregnant women will be asked to demonstrate using a stress ball, and it will be verified that they can use it correctly. Pregnant women will be told to squeeze the ball once and release it 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). In addition, stress balls used in the hospital environment to minimize contamination will be disinfected with disposable asepsis wipes before being given to pregnant women.

Behavioral: Stress Ball Intervention

Interventions

Stress Ball Intervention BEHAVIORAL

The 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.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hümeyra TÜLEK DENİZ: lead

Study Sites (1)

Ondokuz Mayıs University

Samsun, Turkey (Türkiye)

RECRUITING

Related Publications (11)

• Yilmaz D, Kutlu M, Baki E. A comparison of the effect on pain management of two non-pharmacological methods used during administration of Pfizer-BioNTech COVID-19 vaccine (BNT162b2): A randomized controlled study. Jpn J Nurs Sci. 2023 Jul;20(3):e12533. doi: 10.1111/jjns.12533. Epub 2023 Mar 31.

  PMID: 36999594 RESULT

• Yilmaz D, Gunes UY. The effect on pain of three different nonpharmacological methods in peripheral intravenous catheterisation in adults. J Clin Nurs. 2018 Mar;27(5-6):1073-1080. doi: 10.1111/jocn.14133. Epub 2018 Jan 8.

  PMID: 29076581 RESULT

• Hu HQ, Zhang J, Zhao W, Tian T, Huang AQ, Wang LL. [The occurrence and determinants of anxiety and depression symptoms in women of six counties/ districts in China during pregnancy]. Zhonghua Yu Fang Yi Xue Za Zhi. 2017 Jan 6;51(1):47-52. doi: 10.3760/cma.j.issn.0253-9624.2017.01.010. Chinese.

  PMID: 28056270 RESULT

• Quan X, Joseph A, Nanda U, Moyano-Smith O, Kanakri S, Ancheta C, Loveless EA. Improving Pediatric Radiography Patient Stress, Mood, and Parental Satisfaction Through Positive Environmental Distractions: A Randomized Control Trial. J Pediatr Nurs. 2016 Jan-Feb;31(1):e11-22. doi: 10.1016/j.pedn.2015.08.004. Epub 2015 Sep 26.

  PMID: 26395650 RESULT

• Ozen N, Berse S, Tosun B. Effects of using a stress ball on anxiety and depression in patients undergoing hemodialysis: A prospective, balanced, single-blind, crossover study. Hemodial Int. 2023 Oct;27(4):411-418. doi: 10.1111/hdi.13102. Epub 2023 Jun 15.

  PMID: 37318078 RESULT

• Gezginci E, Iyigun E, Yalcin S, Bedir S, Ozgok IY. Comparison of Two Different Distraction Methods Affecting the Level of Pain and Anxiety during Extracorporeal Shock Wave Lithotripsy: A Randomized Controlled Trial. Pain Manag Nurs. 2018 Jun;19(3):295-302. doi: 10.1016/j.pmn.2017.09.005. Epub 2017 Dec 14.

  PMID: 29248604 RESULT

• Gezginci E, Iyigun E, Kibar Y, Bedir S. Three Distraction Methods for Pain Reduction During Cystoscopy: A Randomized Controlled Trial Evaluating the Effects on Pain, Anxiety, and Satisfaction. J Endourol. 2018 Nov;32(11):1078-1084. doi: 10.1089/end.2018.0491.

  PMID: 30280915 RESULT

• Apaydin Cirik V, Turkmen AS, Ayaz M. Effectiveness of stress ball and relaxation exercises on polymerase chain reaction (RRT-PCR) test-induced fear and pain in adolescents in Turkiye. J Pediatr Nurs. 2023 Jul-Aug;71:135-140. doi: 10.1016/j.pedn.2022.12.001. Epub 2022 Dec 14.

  PMID: 36526480 RESULT

• Karatas TC, Gezginci E. The Effect of Using a Stress Ball During Endoscopy on Pain, Anxiety, and Satisfaction: A Randomized Controlled Trial. Gastroenterol Nurs. 2023 Jul-Aug 01;46(4):309-317. doi: 10.1097/SGA.0000000000000739. Epub 2023 May 17.

  PMID: 37199436 RESULT

• Kaasen A, Helbig A, Malt UF, Naes T, Skari H, Haugen G. Maternal psychological responses during pregnancy after ultrasonographic detection of structural fetal anomalies: A prospective longitudinal observational study. PLoS One. 2017 Mar 28;12(3):e0174412. doi: 10.1371/journal.pone.0174412. eCollection 2017.

  PMID: 28350879 RESULT

• Bolnick JM, Garcia G, Fletcher BG, Rayburn WF. Cross-over trial of fetal heart rate response to halogen light and vibroacoustic stimulation. J Matern Fetal Neonatal Med. 2006 Apr;19(4):215-9. doi: 10.1080/14767050500526131.

  PMID: 16854694 RESULT

Related Links

• HÜNEE (Hacettepe Üniversitesi Nüfus Etütler Enstitüsü). (2019). 2018 Türkiye nüfus ve Sağlık Araştırması. Hacettepe Üniversitesi Nüfus Etütler Enstitüsü, T.C. Cumhurbaşkanlığı Strateji ve Bütçe Başkanlığı ve TÜBİTAK, Ankara, Türkiye.
• HÜNEE (Hacettepe Üniversitesi Nüfus Etütler Enstitüsü). (2014). 2014 Türkiye nüfus ve Sağlık Araştırması. Hacettepe Üniversitesi Nüfus Etütler Enstitüsü, T.C. Cumhurbaşkanlığı Strateji ve Bütçe Başkanlığı ve TÜBİTAK, Ankara, Türkiye.
• HÜNEE (Hacettepe Üniversitesi Nüfus Etütler Enstitüsü). (1994). 1994 Türkiye nüfus ve Sağlık Araştırması. Hacettepe Üniversitesi Nüfus Etütler Enstitüsü, T.C. Cumhurbaşkanlığı Strateji ve Bütçe Başkanlığı ve TÜBİTAK, Ankara, Türkiye.
• World Health Organization (WHO) (2018). Available from: Maternal mortality. Erişim Tarihi: 17.04.2023.

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Nazlı BALTACI, RN, PhD

  Ondokuz Mayıs University

  STUDY DIRECTOR

Central Study Contacts

Hümeyra TÜLEK DENİZ, MSc

CONTACT

0 474 242 68 40; humeyra.tulek@gmail.com

Nedime Gül DOĞAN ÖZDEMİR, MSc

CONTACT

0362 312 19 19; nedime.dogan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer

Model Details: The research will be conducted as a two-group, parallel, randomized, controlled experimental study with a pretest-posttest design.

Study Record Dates

• First Submitted: February 10, 2024
• First Posted: March 8, 2024
• Study Start: March 13, 2024
• Primary Completion: June 30, 2025
• Study Completion: August 31, 2025
• Last Updated: December 31, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)