Nursing Care in Threat of Preterm Birth

The Effect of Relaxation-Focused Nursing Care on Stress, Cortisol and Birth Week in Threat of Preterm Birth: A Randomised Controlled Trial

Relaxation-Focused Nursing Care which is formed by using these two models is composed of; positive language, positive environment and reducing stressors. Relaxation-Focused Nursing Care, which is thought to have an effect on delaying birth, consists of four stages as a two-day program.In this study, it is aimed to determine the effect of Relaxation-Focused Nursing Care on stress level, cortisol level and birth week.

Study Overview

• Status: Completed
• Conditions: Nursing Caries
• Intervention / Treatment: Behavioral: Relaxation Focused Nursing Care

Detailed Description

Preterm birth is seen in 7-12% of all pregnant women and according to estimations about 15 million infants are delivered each year. Preterm birth is an extremely important problem in terms of its effects on newborn's health, mother's health, community and economy. Preterm birth causes the newborn chronic pulmonary disease; gastrointestinal, immunologic, central nervous system, auditory and visual problems; long-term motor and cardiovascular system diseases; and cognitive, visual, behavioral disorders. While preterm birth causes the women postpartum anxiety, stress and depression; it also leads to newborn intensive care costs, long-term complex health care needs for families and community and has serious consequences for public service sector such as health insurance, education, other social support systems and economy. Some factors initiate preterm birth, whereas 70-80% of them start spontaneously, remaining 20-30% has iatrogenic origin. It is reported that there is no known and effective treatment for preterm birth. It is reported in literature that stress which is one of the risk factors of preterm birth, causes preterm birth. If stress causes threat of preterm delivery, reducing stress may delay preterm birth and the complications of preterm birth on newborn and mother's health and also its economic and social burden can be reduced. National and international studies related to the effect of coping with stress on threat of preterm birth are lacking. It is thought that preterm birth can be prevented in women with threat of preterm birth through developing mechanisms to cope with stress and reducing stressors. Since nurse provides 24-hour care for woman diagnosed with the threat of preterm birth, the nursing care may be effective in this aspect.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • İzmir, Turkey, 35340
    • Dokuz Eylül University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• to be diagnosed with TPB,
• to be over 18 years of age,
• to know Turkish and
• to agree to participate in the research.

Exclusion Criteria:

• diagnosis of EMR,
• multiple pregnancy,
• admission to hospital with vaginal bleeding,
• psychiatric, chronic and pregnancy-related disease developing,
• to want to quit the study at any stage after agreeing to participate in the study, and
• delivery at any stage after the data collection process has been completed after agreeing to participate in the trial.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; In the intervention group; informed consent forms, Relaxation Focused Nursing Care and routine nursing care in the hospital were performed. Then data collection tools were applied.	Behavioral: Relaxation Focused Nursing Care; "Relaxation Focused Nursing Care" is composed of HypnoBirthing and Transactional Model. Hypnobirthing Philosophy is based on the laws of mind and aims to create positive thoughts and emotions. The Transactional Model defines stress as a special relationship between the person and the environment. Therefore, Relaxation Focused Nursing Care; positive language, positive environment and reducing stressors.; Other Names: Information
No Intervention: Control group; Women in the control group received routine nursing care in the hospital and data collection tools were applied at the same hours as the intervention group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Birth weeks of Intervention and Control Groups	Comparison of birth weeks between intervention and control groups	20 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stress level of Intervention and Control Groups	Comparison of stress level between intervention and control groups, physiological parameter	2 days

Collaborators and Investigators

• Sponsor: Hülya Özberk
• Collaborators: Dokuz Eylul University
• Investigators: Principal Investigator: Hülya Özberk, PhD, Dokuz Eylül University; Study Director: Samiye Mete, PhD, University of Kyrenia; Study Director: Murat Bektaş, PhD, Dokuz Eylül University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): May 24, 2019

Study Registration Dates

• First Submitted: August 1, 2019
• First Submitted That Met QC Criteria: August 2, 2019
• First Posted (Actual): August 5, 2019

Study Record Updates

• Last Update Posted (Actual): August 5, 2019
• Last Update Submitted That Met QC Criteria: August 2, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Relaxation
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: DokuzEU12345

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No