Heat Application to the Sacral Region and Pain Level During the First Stage of Labor

NCT06297031 | Completed

• 1 other identifier: 2020/20
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to determine the effect of hot application applied to the sacral region during first stage of labor on women's pain level and labor process.

Conditions

Heat Exposure; Labor Pain; Apgar Score; Duration of Labor

Outcome Measures

Primary Outcomes (1)

• Change From Baseline labor Pain at three times

  It will be assessed three times during the first stage of the labor with Number Rating Scale. Pain intensity measured on a Number Rating Scale with scores ranging from 0 - 10. Pain increases as the score increases. The high point describes bad outcome.

  The pain was evaluated three times during labor

Secondary Outcomes (3)

• Duration of the first stage of labor

  through study completion, an average of 1 day

• Change From Baseline APGAR score after delivery

  After delivery in two times at first and fifth minutes through study completion, an average of 1 day

• Change From Baseline Fetal Heart Rate

  A total of three measurement results were obtained (after the cervical dilatation was evaluated as 3-4 cm, 5-6 cm and 7-8 cm)

Study Arms (2)

heat application

EXPERIMENTAL

women in the intervention group were treated with hot water application to the sacral region during the first stage of labor. When the cervical dilatation was 3-4 cm, 5-6 cm and 7-8 cm, heat application was applied a total of 3 times.

Other: heat application

no heat application

NO INTERVENTION

No treatment was performed on women in the control group during the study. In the clinic, women's cervical dilatation is routinely checked by the midwife every 2-3 hours, and the progress of labor is monitored by fetal heart rate and fetal monitoring

Interventions

heat application OTHER

• Thermophore Application: Before the application, the thermophore was wrapped in a towel to prevent skin damage. Studies in the literature indicate that the surface temperature of the thermophore should be 38-45 °C. For this reason, water with a temperature of 70°C when measured with a thermometer was added into the thermophore. Similarly, studies in the literature indicate that thermophore application should be applied for 10-30 minutes. Therefore, the application takes 20 minutes. The researcher stayed with the woman for 20 minutes.

heat application

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women were over 18 years of age
• Primipara
• Volunteered to participate in the study
• Were in the latent phase of labor (cervical dilatation 1-2 cm)
• Had a single fetus in vertex presentation
• Had no history of pregnancy complications
• Had not undergone any intervention in the sacral region were included in the study

You may not qualify if:

• Applied pharmacological pain control methods in the first stage of labor
• Had a cesarean section decision at any stage

Sponsors & Collaborators

• Istanbul Demiroglu Bilim University: lead

Study Sites (1)

Demiroglu Bilim University

Istanbul, 34384, Turkey (Türkiye)

Location

Related Publications (2)

• Goswami S, Jelly P, Sharma SK, Negi R, Sharma R. The effect of heat therapy on pain intensity, duration of labor during first stage among primiparous women and Apgar scores: A systematic review and meta-analysis. Eur J Midwifery. 2022 Nov 28;6:66. doi: 10.18332/ejm/156487. eCollection 2022.

  PMID: 36474673 BACKGROUND

• Kaur J, Sheoran P, Kaur S, Sarin J. Effectiveness of Warm Compression on Lumbo-Sacral Region in Terms of Labour Pain Intensity and Labour Outcomes among Nulliparous: an Interventional Study. J Caring Sci. 2020 Mar 1;9(1):9-12. doi: 10.34172/jcs.2020.002. eCollection 2020 Mar.

  PMID: 32296653 BACKGROUND

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tülay KAVLAK

  Istanbul Demiroglu Bilim University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: March 6, 2024
• Study Start: April 1, 2020
• Primary Completion: May 1, 2021
• Study Completion: May 30, 2021
• Last Updated: March 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)