Birth Environment and Childbirth-stress, Control & Outcome

Sponsor
National Taipei University of Nursing and Health Sciences (Other)
Overall Status
Recruiting
CT.gov ID
NCT04888013
Collaborator
Taoyuan General Hospital (Other)
129
1
3
17.7
7.3

Study Details

Study Description

Brief Summary

This research improves the correlation between birth control and birth outcomes by understanding the childbirth environment and birth stress. A Quasi Experiment research . The sample size was calculated using a two-tailed test, the significance level α was 0.05, the power was 80%, three groups of repeated measurements were taken three times, the effect size (effect size) was set to medium.25, and the required number of samples was 108 people, resulting in a 20% wastage rate, a total of 129 people are needed, so each of the three groups is expected to accept 43 people.

Condition or Disease Intervention/Treatment Phase
  • Other: Positive Birth Environment
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
129 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
The Impact of Birth Environment and Childbirth-stress, Birth Control & Outcome
Actual Study Start Date :
Jul 21, 2021
Anticipated Primary Completion Date :
Jan 12, 2023
Anticipated Study Completion Date :
Jan 12, 2023

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: control group

Routine care for childbirth

Other: Positive Birth Environment
The intent is to surround the woman and her caregivers with specific types of auditory, visual, and tactile stim uli. One key feature of the ambient room is what is missing-the standard hospital bed. As an alternative, a portable double-sized mattress with several large pillows is set up in a corner of the room. The intent is to allow the woman freedom in positioning and to permit close contact with support people, and to limit the routine use of continuous elec tronic fetal heart rate monitoring and other technologies during normal labor. Lighting is dimmed. A wide variety of music selections are also available.

Experimental: experimental 2

Building childbirth environment

Other: Positive Birth Environment
The intent is to surround the woman and her caregivers with specific types of auditory, visual, and tactile stim uli. One key feature of the ambient room is what is missing-the standard hospital bed. As an alternative, a portable double-sized mattress with several large pillows is set up in a corner of the room. The intent is to allow the woman freedom in positioning and to permit close contact with support people, and to limit the routine use of continuous elec tronic fetal heart rate monitoring and other technologies during normal labor. Lighting is dimmed. A wide variety of music selections are also available.

Experimental: experimental 1

Building childbirth environment and labor delivery recovery room

Other: Positive Birth Environment
The intent is to surround the woman and her caregivers with specific types of auditory, visual, and tactile stim uli. One key feature of the ambient room is what is missing-the standard hospital bed. As an alternative, a portable double-sized mattress with several large pillows is set up in a corner of the room. The intent is to allow the woman freedom in positioning and to permit close contact with support people, and to limit the routine use of continuous elec tronic fetal heart rate monitoring and other technologies during normal labor. Lighting is dimmed. A wide variety of music selections are also available.

Outcome Measures

Primary Outcome Measures

  1. Visual Analogue Stress Scale [From latent phase to postpartum 2 hours]

    The visual analogue scale for stress is a horizontal line of 0-10 cm. It is divided into the maximum level of stress. 0 means no stress at all, and 10 means extreme stress. The individual will point out the most suitable value for the feeling at this moment. Centimeters represent one point, and fractions gradually represent a decrease in the score

  2. salivary amylase [From latent phase to postpartum 2 hours]

    he measurement standard values are as follows: 30 kIU/L is no pressure; 31~45 kIU/L is a small amount of pressure; 46~60 kIU/L is a moderate pressure; more than 61 kIU/L is a severe pressure.

  3. Heart rate variability [From latent phase to postpartum 2 hours]

    The heart rate variability measurement uses TS-0411 sample, wrist-type physiological monitor (approved by the Department of Health No. 5200277), with multiple built-in biological sensors, which have been calibrated before leaving the factory to achieve high accuracy.

Secondary Outcome Measures

  1. Perception of Childbirth Environment Scale [through study completion, an average of Postpartum 24 hours]

    Using LIKERT-5, the higher the score, the better the environmental experience

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. Be at least 20 years old,

  2. Those who agree to participate in this research and can read and write Chinese,

  3. vaginal delivery

  4. Those who have no high-risk complications or chronic diseases during pregnancy and childbirth.

Exclusion Criteria:
  1. Those who have been diagnosed with mental illness by a doctor, including those with depression and mood disorders

  2. Exclude stillbirths and newborns with congenital abnormalities

Contacts and Locations

Locations

Site City State Country Postal Code
1 Taoyuan General Hospital Taoyuan Taiwan 33004

Sponsors and Collaborators

  • National Taipei University of Nursing and Health Sciences
  • Taoyuan General Hospital

Investigators

  • Principal Investigator: Ll-li Chen, PhD Student, National Taipei University of Nursing and Health Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Li-li Chen, RN PhD student, National Taipei University of Nursing and Health Sciences
ClinicalTrials.gov Identifier:
NCT04888013
Other Study ID Numbers:
  • TYGH109064
First Posted:
May 17, 2021
Last Update Posted:
Apr 6, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Li-li Chen, RN PhD student, National Taipei University of Nursing and Health Sciences

Study Results

No Results Posted as of Apr 6, 2022