Skip to main content
Clinical Trials/NCT04045197
NCT04045197CompletedNot Applicable

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

Hülya Özberk1 site in 1 country66 target enrollmentStarted: August 1, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
66
Locations
1
Primary Endpoint
Birth weeks of Intervention and Control Groups

Study Overview

Brief Summary

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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Participant)

Masking Description

Single Blind Randomised Controlled Trial

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

Intervention group

Experimental

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.

Intervention: Relaxation Focused Nursing Care (Behavioral)

Control group

No Intervention

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.

Outcomes

Primary Outcomes

Birth weeks of Intervention and Control Groups

Time Frame: 20 weeks

Comparison of birth weeks between intervention and control groups

Secondary Outcomes

  • Stress level of Intervention and Control Groups(2 days)

Investigators

Sponsor
Hülya Özberk
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Hülya Özberk

Research Assistant,Deparment of Obstetric-Women's Diseases Nursing,Principal Investigator

Dokuz Eylul University

Study Sites (1)

Loading locations...

Similar Trials

Nursing Care in Threat of Preterm Birth | Clinical Trial