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Completed

NCT Number: NCT04045197

Nursing Care in Threat of Preterm Birth

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.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dokuz Eylul University

Izmir, 35340, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Relaxation Focused Nursing Care

Behavioral

"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

Primary outcomes

  1. Birth weeks of Intervention and Control Groups

    Time frame: 20 weeks

    Comparison of birth weeks between intervention and control groups

Secondary outcomes

  1. Stress level of Intervention and Control Groups

    Time frame: 2 days

    Comparison of stress level between intervention and control groups, physiological parameter

Sponsors and collaborators

Lead sponsor

Hülya Özberk

Other

Collaborators

  • Dokuz Eylul University

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Aug 5, 2019
Registry last updated
Aug 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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