Clinical trial NCT04045197: Nursing Care in Threat of Preterm Birth
Official title: The Effect of Relaxation-Focused Nursing Care on Stress, Cortisol and Birth Week in Threat of Preterm Birth: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nursing Caries
Keywords: Relaxation
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
Collaborators: name: Dokuz Eylul University
First posted: 2019-08-05
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised Controlled Trial
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Birth weeks of Intervention and Control Groups
timeFrame: 20 weeks
Secondary outcomes:
measure: Stress level of Intervention and Control Groups
timeFrame: 2 days
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Dokuz Eylul University
Study officials:
affiliation: Dokuz Eylul University
name: Hülya Özberk, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Kyrenia
name: Samiye Mete, PhD
role: STUDY_DIRECTOR
affiliation: Dokuz Eylul University
name: Murat Bektaş, PhD
role: STUDY_DIRECTOR
References: