The Effect of Lower Back Massage on Perceived Labor Pain
Primary Purpose
Labor Pain
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
lower back massage
Sponsored by
About this trial
This is an interventional supportive care trial for Labor Pain
Eligibility Criteria
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
Sites / Locations
- Burcu Tuncer Yilmaz
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
control group
Arm Description
pregnant women undergoing lower back massage
pregnant women given routine care
Outcomes
Primary Outcome Measures
assessment of change in pain scores with lower back massage
Lower back massage is a non-pharmacological method to reduce perceived labor pain.
Secondary Outcome Measures
Full Information
NCT ID
NCT05222867
First Posted
December 14, 2021
Last Updated
January 31, 2022
Sponsor
Eskisehir Osmangazi University
1. Study Identification
Unique Protocol Identification Number
NCT05222867
Brief Title
The Effect of Lower Back Massage on Perceived Labor Pain
Official Title
Angle Labor Pain Questionnaire Turkish Version: Validity and Reliability Study and Evaluation of Efficacy With a Non-pharmacological Method
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
July 30, 2020 (Actual)
Study Completion Date
July 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eskisehir Osmangazi University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
pregnant women undergoing lower back massage
Arm Title
control group
Arm Type
No Intervention
Arm Description
pregnant women given routine care
Intervention Type
Procedure
Intervention Name(s)
lower back massage
Intervention Description
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
Primary Outcome Measure Information:
Title
assessment of change in pain scores with lower back massage
Description
Lower back massage is a non-pharmacological method to reduce perceived labor pain.
Time Frame
Change in perceived labor pain scores in an average of 30 minutes (During the lower back massage application)
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
pregnancy
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
NEBAHAT OZERDOGAN, PROF.DR.
Organizational Affiliation
ESKISEHIR OSMANGAZI UNIVERSITY FACULTY OF HEALTH SCIENCES DEPARTMENT OF MIDWIFERY
Official's Role
Study Director
Facility Information:
Facility Name
Burcu Tuncer Yilmaz
City
Eskişehir
ZIP/Postal Code
26250
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27870739
Citation
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.
Results Reference
background
PubMed Identifier
20229219
Citation
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.
Results Reference
background
PubMed Identifier
20219349
Citation
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.
Results Reference
background
PubMed Identifier
27685468
Citation
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.
Results Reference
result
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The Effect of Lower Back Massage on Perceived Labor Pain
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