Nursing Care in Threat of Preterm Birth

NCT04045197 | Completed

• 1 other identifier: DokuzEU12345
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Nursing Caries

Keywords

Relaxation

Outcome Measures

Primary Outcomes (1)

• Birth weeks of Intervention and Control Groups

  Comparison of birth weeks between intervention and control groups

  20 weeks

Secondary Outcomes (1)

• Stress level of Intervention and Control Groups

  2 days

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Behavioral: Relaxation Focused Nursing Care

Control group

NO INTERVENTION

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.

Interventions

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.

Also known as: Information

Intervention group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: To be over 18 years of age
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• to be diagnosed with TPB,
• to be over 18 years of age,
• to know Turkish and
• to agree to participate in the research.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hülya Özberk: lead
• Dokuz Eylul University: collaborator

Study Sites (1)

Dokuz Eylul University

Izmir, 35340, Turkey (Türkiye)

Location

Study Officials

• Hülya Özberk, PhD

  Dokuz Eylul University

  PRINCIPAL INVESTIGATOR

• Samiye Mete, PhD

  University of Kyrenia

  STUDY DIRECTOR

• Murat Bektaş, PhD

  Dokuz Eylul University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single Blind Randomised Controlled Trial
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Assistant,Deparment of Obstetric-Women's Diseases Nursing,Principal Investigator

Model Details: Randomised Controlled Trial

Study Record Dates

• First Submitted: August 1, 2019
• First Posted: August 5, 2019
• Study Start: August 1, 2017
• Primary Completion: January 1, 2018
• Study Completion: May 24, 2019
• Last Updated: August 5, 2019

Record last verified: 2019-08

Locations

TU (1)