NCT05222867

Brief Summary

The aim of the study was to assesment the change in pain scores with lower back massage, a non-pharmacological method, on perceived labor pain in the early active phase of the first stage of labor.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2020

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 14, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 3, 2022

Completed
Last Updated

February 3, 2022

Status Verified

January 1, 2022

Enrollment Period

8 months

First QC Date

December 14, 2021

Last Update Submit

January 31, 2022

Conditions

Labor Pain

Outcome Measures

Primary Outcomes (1)

  • assessment of change in pain scores with lower back massage

    Lower back massage is a non-pharmacological method to reduce perceived labor pain.

    Change in perceived labor pain scores in an average of 30 minutes (During the lower back massage application)

Study Arms (2)

Intervention

EXPERIMENTAL

pregnant women undergoing lower back massage

Procedure: lower back massage

control group

NO INTERVENTION

pregnant women given routine care

Interventions

lower back massagePROCEDURE

Lower back massage performance: In the study, Linda Kimber's massage protocol was used. First, the researcher ensured that the patient was holding the bed, squatting, or bent over on the bed, which is suitable for the massage, between two contractions. The pregnant woman was instructed to breathe deeply and exhale audibly when her contractions began. Gloves were worn during the massage and liquid Vaseline, which does not contain any active substance, was used to provide lubricity. The circular hip massage was applied at the beginning of the contraction, and lower lateral area and sacral pressure massage was applied towards the end of the contraction as per the massage protocol, and simultaneously with the inhaling sound of the pregnant woman

Intervention

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnancy
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • The study group consisted of pregnant women who were at 37-40 weeks of pregnancy,
  • had cervical dilatation of 4-6 cm,
  • had a single, live, and vertex fetus,
  • had an uncomplicated pregnancy,
  • had no contraction anomalies,
  • could communicate in Turkish
  • planned for a vaginal delivery.

You may not qualify if:

  • with cognitive dysfunction
  • using narcotic analgesics or sedative drugs
  • had any contraindications for applying a back massage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Burcu Tuncer Yilmaz

Eskişehir, 26250, Turkey (Türkiye)

Location

Related Publications (4)

  • Angle PJ, Kurtz Landy C, Djordjevic J, Barrett J, Kibbe A, Sriparamananthan S, Lee Y, Hamata L, Zaki P, Kiss A. Performance of the Angle Labor Pain Questionnaire During Initiation of Epidural Analgesia in Early Active Labor. Anesth Analg. 2016 Dec;123(6):1546-1553. doi: 10.1213/ANE.0000000000001679.

    PMID: 27870739BACKGROUND

  • Angle P, Landy CK, Charles C, Yee J, Watson J, Kung R, Kronberg J, Halpern S, Lam D, Lie LM, Streiner D. Phase 1 development of an index to measure the quality of neuraxial labour analgesia: exploring the perspectives of childbearing women. Can J Anaesth. 2010 May;57(5):468-78. doi: 10.1007/s12630-010-9289-1. Epub 2010 Mar 13.

    PMID: 20229219BACKGROUND

  • Capogna G, Camorcia M, Stirparo S, Valentini G, Garassino A, Farcomeni A. Multidimensional evaluation of pain during early and late labor: a comparison of nulliparous and multiparous women. Int J Obstet Anesth. 2010 Apr;19(2):167-70. doi: 10.1016/j.ijoa.2009.05.013. Epub 2010 Mar 9.

    PMID: 20219349BACKGROUND

  • Angle P, Kurtz-Landy C, Djordjevic J, Barrett J, Kibbe A, Sriparamananthan S, Lee Y, Hamata L, Kiss A. The Angle Labor Pain Questionnaire: Reliability, Validity, Sensitivity to Change, and Responsiveness During Early Active Labor Without Pain Relief. Clin J Pain. 2017 Feb;33(2):132-141. doi: 10.1097/AJP.0000000000000386.

    PMID: 27685468RESULT

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • NEBAHAT OZERDOGAN, PROF.DR.

    ESKISEHIR OSMANGAZI UNIVERSITY FACULTY OF HEALTH SCIENCES DEPARTMENT OF MIDWIFERY

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 14, 2021

First Posted

February 3, 2022

Study Start

December 1, 2019

Primary Completion

July 30, 2020

Study Completion

July 30, 2020

Last Updated

February 3, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)