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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05222867
Other study ID # ALPQT_NONFARMA
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2019
Est. completion date July 30, 2020

Study information

Verified date January 2022
Source Eskisehir Osmangazi University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date July 30, 2020
Est. primary completion date July 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 49 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Turkey Burcu Tuncer Yilmaz Eskisehir

Sponsors (1)

Lead Sponsor Collaborator
Eskisehir Osmangazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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 — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
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