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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04045197
Enrollment
66
Registered
2019-08-05
Start date
2017-08-01
Completion date
2019-05-24
Last updated
2019-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nursing Caries

Keywords

Relaxation

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.

Interventions

BEHAVIORALRelaxation 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.

Sponsors

Dokuz Eylul University
CollaboratorOTHER
Hülya Özberk
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Masking description

Single Blind Randomised Controlled Trial

Intervention model description

Randomised Controlled Trial

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Birth weeks of Intervention and Control Groups20 weeksComparison of birth weeks between intervention and control groups

Secondary

MeasureTime frameDescription
Stress level of Intervention and Control Groups2 daysComparison of stress level between intervention and control groups, physiological parameter

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026