The Effect of Lower Back Massage on Perceived Labor Pain

• Sponsor: Eskisehir Osmangazi University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05222867
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Actual Duration (Months): 8
• Patients Per Site Per Month: 7.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Labor Pain	Procedure: lower back massage	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Angle Labor Pain Questionnaire Turkish Version: Validity and Reliability Study and Evaluation of Efficacy With a Non-pharmacological Method
• Actual Study Start Date: Dec 1, 2019
• Actual Primary Completion Date: Jul 30, 2020
• Actual Study Completion Date: Jul 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention pregnant women undergoing lower back massage	Procedure: lower back massage; 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
No Intervention: control group pregnant women given routine care

Outcome Measures

Primary Outcome Measures

1. assessment of change in pain scores with lower back massage [Change in perceived labor pain scores in an average of 30 minutes (During the lower back massage application)]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 49 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 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.

Exclusion Criteria:

• with cognitive dysfunction

• using narcotic analgesics or sedative drugs

• had any contraindications for applying a back massage

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Burcu Tuncer Yilmaz	Eskişehir		Turkey	26250

Sponsors and Collaborators

• Eskisehir Osmangazi University

Investigators

• Study Director: NEBAHAT OZERDOGAN, PROF.DR., ESKISEHIR OSMANGAZI UNIVERSITY FACULTY OF HEALTH SCIENCES DEPARTMENT OF MIDWIFERY

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 4, 2021

More Information

Publications

• 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.
• 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.
• 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.

• Responsible Party: Burcu Tuncer Yilmaz, Principal Investigator, Eskisehir Osmangazi University
• ClinicalTrials.gov Identifier: NCT05222867
• Other Study ID Numbers: ALPQT_NONFARMA
• First Posted: Feb 3, 2022
• Last Update Posted: Feb 3, 2022
• Last Verified: Jan 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
• Additional relevant MeSH terms: Labor Pain

Study Results

No Results Posted as of Feb 3, 2022