Nursing Care in Threat of Preterm Birth
Primary Purpose
Nursing Caries
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Relaxation Focused Nursing Care
Sponsored by

About this trial
This is an interventional supportive care trial for Nursing Caries focused on measuring Relaxation
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.
Sites / Locations
- Dokuz Eylul University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Birth weeks of Intervention and Control Groups
Comparison of birth weeks between intervention and control groups
Secondary Outcome Measures
Stress level of Intervention and Control Groups
Comparison of stress level between intervention and control groups, physiological parameter
Full Information
NCT ID
NCT04045197
First Posted
August 1, 2019
Last Updated
August 2, 2019
Sponsor
Hülya Özberk
Collaborators
Dokuz Eylul University
1. Study Identification
Unique Protocol Identification Number
NCT04045197
Brief Title
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
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
January 1, 2018 (Actual)
Study Completion Date
May 24, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hülya Özberk
Collaborators
Dokuz Eylul University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nursing Caries
Keywords
Relaxation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised Controlled Trial
Masking
Participant
Masking Description
Single Blind Randomised Controlled Trial
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Relaxation Focused Nursing Care
Other Intervention Name(s)
Information
Intervention Description
"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.
Primary Outcome Measure Information:
Title
Birth weeks of Intervention and Control Groups
Description
Comparison of birth weeks between intervention and control groups
Time Frame
20 weeks
Secondary Outcome Measure Information:
Title
Stress level of Intervention and Control Groups
Description
Comparison of stress level between intervention and control groups, physiological parameter
Time Frame
2 days
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
To be over 18 years of age
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hülya Özberk, PhD
Organizational Affiliation
Dokuz Eylul University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Samiye Mete, PhD
Organizational Affiliation
University of Kyrenia
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Murat Bektaş, PhD
Organizational Affiliation
Dokuz Eylul University
Official's Role
Study Director
Facility Information:
Facility Name
Dokuz Eylul University
City
İzmir
ZIP/Postal Code
35340
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Nursing Care in Threat of Preterm Birth
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