NCT04382833

Brief Summary

Aim: This study aimed to examine the effects of sacral massage and hot application on labor pain and comfort level perceptions in pregnant women. Methods: This randomized controlled experimental study included hot application, massage and control groups, each having 30 primiparous pregnant women whose cervix was dilated to 4-5 cm. The intervention groups were given a sacral massage or sacral hot application, whereas the control group was given only standard midwifery care during 4-5, 6-7, and 8-9 cm cervical dilation. The data were collected using the Introductory Information Form, the Childbirth Comfort Questionnaire (CCQ), and the Numerical Rating Scale (NRS).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

May 4, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 11, 2020

Completed
Last Updated

May 11, 2020

Status Verified

May 1, 2020

Enrollment Period

6 months

First QC Date

May 4, 2020

Last Update Submit

May 6, 2020

Conditions

Keywords

comfort at laborlabor painhot applicationmassage

Outcome Measures

Primary Outcomes (2)

  • severity of labor pain assessed by Numerical Rating Scale

    Labor pain level, Numerical Rating Scale

    4-5 cm, 6-7 cm and 8-9 cm cervical dilation at labor

  • comfort level at labor

    Comfort level, Childbirth Comfort Questionnaire

    4-5 cm and 8-9 cm cervical dilation at labor

Study Arms (3)

HOT APPLICATION GROUP

EXPERIMENTAL

Thermoforming, one of the dry hot application methods, was performed on the sacral (S1-S4) vertebrae region of pregnant women in the hot application group while they were in sitting or left-side-lying position (during 4-5, 6-7, and 8-9 cm cervical dilation). Thermoforming was applied by wrapping it with a towel to protect pregnant women from the direct effect of its hot surface. The mean water temperature used in thermoforming was 50C. The water temperature was measured using a liquid thermometer. When 50°C water was subjected to hot application, the surface temperature reached around 40°C. The hot application was carried out continuously for 20 min.20 The body temperature of the pregnant women was evaluated before the application.

Other: HOT APPLICATION

MASSAGE GROUP

EXPERIMENTAL

Massage using effleurage and friction techniques was applied to the 4-5 cm right and left lateral parts of the midline on the sacral (S1-S4) vertebrae region of pregnant women in the massage application group while they were in sitting or left-side-lying position (during 4-5, 6-7, and 8-9 cm cervical dilation). The massage application was carried out continuously for only 10 min because it was thought to cause irritation to the area where it was practiced.

Other: MASSAGE

CONTROL GROUP

NO INTERVENTION

Interventions

HOT APPLICATION

HOT APPLICATION GROUP
MASSAGEOTHER
MASSAGE GROUP

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant womens
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • primiparous pregnant women
  • vaginal delivery expectancy
  • term pregnancy
  • single healthy fetus
  • active labor stage (4-5 cm cervikal dilation)

You may not qualify if:

  • multioarous pregnant women
  • preterm labor
  • multiple pregnancy
  • complicated pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Labor Pain

Interventions

Massage

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer (PhD)

Study Record Dates

First Submitted

May 4, 2020

First Posted

May 11, 2020

Study Start

June 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

May 11, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share