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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05335681
Other study ID # Hayat01
Secondary ID Phd midwifery st
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date April 1, 2022
Est. completion date March 15, 2023

Study information

Verified date February 2023
Source Gulhane School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The use of non-pharmacological methods in labor pain is very important in order to improve the birth process, increase comfort and provide relaxation. The role of midwives, acting as patient advocate is to maintain comfort throughout the birth process. In order to do this, she should know very well the non-pharmacological methods to be applied to the pregnant woman and choose the most appropriate one. Applying a warm shower, which is one of the non-pharmacological methods; the uterus Increases perfusion, makes labor painless felt, increases the release of oxytocin, and decreases the release of stress hormones. In addition, while reducing the intervention rates, it improves birth and newborn outcomes and affects positively. Purpose of the research; labor pain of warm shower application, labor to evaluate the effect on satisfaction and birth outcomes.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 68
Est. completion date March 15, 2023
Est. primary completion date March 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: - Between the ages of 18 and 35, - Between 37 and 42 weeks of pregnancy, - Planning a normal birth, - Does not have a chronic health problem, - At least 20 minutes of non-stress test (NST) tracing is reactive, - Those without premature rupture of membranes (EMR) or those with PROM Not exceeding 6 hours from the opening time of the membranes, - Speaking Turkish and not having any communication barriers, - Including pregnant women who voluntarily accepted to participate in the study will be. Exclusion Criteria: - The mother's refusal to be involved in the study - The use of analgesic methods during the birth process, - Abnormal changes in fetal heartbeats, - Unexpected complications (Dizziness, fatigue) - Pregnant women who decided to have an emergency cesarean section

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
WARM SHOWER APPLICATION
Experimental group; At least when the cervical opening is 4 cm (Latent phase) and 7 cm (Active phase) While the 20-minute hot shower (37 °C) intervention was performed, the control group only will receive standard care. hot shower; sacrum, lower abdomen and groin areas will be applied. Since possible complications may be encountered, pregnant women The researcher will be accompanied and sit safely in the chair. will be provided. VAS scale twice, before and after the intervention will be applied. Birth satisfaction scale before discharge will be applied.

Locations

Country Name City State
Turkey Öznur Hayat Öktem Karabük

Sponsors (1)

Lead Sponsor Collaborator
Gulhane School of Medicine

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Labor Pain Visual analog scale:On a 10 cm (100 mm.) ruler, which is marked painlessness on one end and the most severe pain possible on the other, the patient expresses his or her own pain by drawing a line, pointing or pointing. The length of the distance from the point where there is no pain to the point marked by the patient is measured in centimeters and the numerical value found shows the severity of the patient's pain. Baseline (Before the intervention)
Primary Labor pain Visual analog scale.On a 10 cm (100 mm.) ruler, which is marked painlessness on one end and the most severe pain possible on the other, the patient expresses his or her own pain by drawing a line, pointing or pointing. The length of the distance from the point where there is no pain to the point marked by the patient is measured in centimeters and the numerical value found shows the severity of the patient's pain. 10 minutes after the intervention
Primary Labor pain Visual analog scale.On a 10 cm (100 mm.) ruler, which is marked painlessness on one end and the most severe pain possible on the other, the patient expresses his or her own pain by drawing a line, pointing or pointing. The length of the distance from the point where there is no pain to the point marked by the patient is measured in centimeters and the numerical value found shows the severity of the patient's pain. 20 minutes after the intervention
Secondary Birth satisfaction The birth satisfaction scale (BSS).The scale is likert type and is scored as Strongly agree:5, Agree:4, Undecided:3, Disagree:2, Strongly disagree:1. Items 4, 8, 12, 15, 16, 17, 19, 20, 21, 23, 25, 29 are scored in reverse on the scale. The original form of the scale consists of 30 items, and the score that can be obtained from the scale varies between 30-150 points. As the score obtained from the scale increases, the satisfaction with the birth increases. Pregnant women in both groups will be visited by the researcher in the postpartum service within the first 12 hours postpartum and BSC will be applied.
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