Nursing Care in Threat of Preterm Birth

NCT ID: NCT04045197

Last Updated: 2019-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2019-05-24

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.

Conditions

Nursing Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Intervention group

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.

Group Type: EXPERIMENTAL

Relaxation Focused Nursing Care

Intervention Type: 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.

Control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Information

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Dokuz Eylul University

OTHER

Sponsor Role: collaborator

Hülya Özberk

OTHER

Sponsor Role: lead

Responsible Party

Hülya Özberk

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

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Hülya Özberk, PhD

Role: PRINCIPAL_INVESTIGATOR

Dokuz Eylul University

Samiye Mete, PhD

Role: STUDY_DIRECTOR

University of Kyrenia

Murat Bektaş, PhD

Role: STUDY_DIRECTOR

Dokuz Eylul University

Locations

Dokuz Eylul University

Izmir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

DokuzEU12345

Identifier Type: -

Identifier Source: org_study_id