Nursing Care in Threat of Preterm Birth

Nursing Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04045197
• Other study ID #: DokuzEU12345
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: May 24, 2019

Study information

• Verified date: August 2019
• Source: Dokuz Eylul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: May 24, 2019
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nursing Caries
• Premature Birth

Intervention

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.

Locations

Country	Name	City	State
Turkey	Dokuz Eylul University	Izmir

Sponsors (2)

Lead Sponsor	Collaborator
Hülya Özberk	Dokuz Eylul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Birth weeks of Intervention and Control Groups	Comparison of birth weeks between intervention and control groups	20 weeks
Secondary	Stress level of Intervention and Control Groups	Comparison of stress level between intervention and control groups, physiological parameter	2 days