The Effect of External Pressure Applı̇ed to the Palm on Labor Paı̇n and Childbirth Experı̇ence

NCT06106867 | Completed

• 1 other identifier: IUC-ENC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The study was carried out to evaluate the effect of external pressure applied to the palm on labor pain and childbirth experience.The sample of the randomized controlled study consisted of 60 nulliparous (30 in the experimental group and 30 in the control group) pregnant women who presented to Zeynep Kamil Gynecology and Pediatrics Training and Research Hospital between April and June 2020 to give birth and met the research conditions. The Descriptive Information Form, Follow-Up Form Related to Labor Action, Childbirth Experience Questionnaire (CEQ), and Visual Analogue Scale (VAS) were used in data collection. During the 5-6 cm, 7-8 cm, and 9-10 cm cervical dilatation stages of the labor process, palm external pressure was applied to the pregnant women in the experimental group, while standard midwifery care was provided to the pregnant women in the control group. The VAS was applied to both groups at admission to the hospital, before and after the 5-6 cm, 7-8 cm, and 9-10 cm cervical dilatation stages, and also at the 30th minute postpartum. Data were analyzed Statistical Package for Social Sciences 24.0 program using number, percentage, mean, standard deviation, the Kolmogorov-Smirnov test, Levene's test and independent samples t-test, one-way ANOVA test, analysis of variance, and chi-square test. In all analyses, p\<0.05 values will be considered statistically significant.

Conditions

Labor Pain

Keywords

external pressure; labor pain; childbirth experience; non-pharmacological method; midwifery care

Outcome Measures

Primary Outcomes (2)

• Visual Analogue Scale (VAS) Level of labor pain will be measured with VAS.

  (min:0, max:10)

  30 minutes

• The Childbirth Experience Questionnaire (CEQ)

  At the 30th minute postpartum

Study Arms (2)

Experimental Group

EXPERIMENTAL

Information about applying external pressure to the palm was provided to the pregnant women in the experimental group. The researcher practically explained how, when and for how long to apply external pressure to the palm. The researcher introduced the comb to be used in the application of external pressure to the palm, and the application stage of the study was started.

Procedure: External pressure to the palm

Control Group

NO INTERVENTION

Routine midwifery care and services applied to all pregnant women in the hospital were provided to the participants in the control group.

Interventions

External pressure to the palm PROCEDURE

During the 5-6 cm, 7-8 cm, and 9-10 cm cervical dilatation stages of the labor process, palm external pressure was applied to the pregnant women in the experimental group.

Experimental Group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Being aged between 18-35 years
• Being a nulliparous pregnant woman
• Being pregnant at term (between the 37th and 42nd weeks of gestation)
• Expecting the vaginal delivery
• Being in singleton and vertex presentation
• The weight of the fetus between 2500-4000 g
• Having had an uncomplicated pregnancy process for the pregnant woman and the fetus
• Being in the latent phase (cervical dilatation below 4 cm)

You may not qualify if:

• Having high-risk pregnancy
• Having any disease and disability related to the hand and palm
• Having any health problem preventing communication
• Being a pregnant woman in need of analgesics
• Pregnant women to whom non-pharmacological methods were applied to relieve pain
• Undergoing cesarean section due to possible indication

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, 34500, Turkey (Türkiye)

Location

Related Publications (16)

• Abdul-Sattar Khudhur Ali S, Mirkhan Ahmed H. Effect of Change in Position and Back Massage on Pain Perception during First Stage of Labor. Pain Manag Nurs. 2018 Jun;19(3):288-294. doi: 10.1016/j.pmn.2018.01.006. Epub 2018 Apr 19.

  PMID: 29680213 BACKGROUND

• ACOG Committee Opinion No. 766: Approaches to Limit Intervention During Labor and Birth. Obstet Gynecol. 2019 Feb;133(2):e164-e173. doi: 10.1097/AOG.0000000000003074.

  PMID: 30575638 BACKGROUND

• Bijur PE, Silver W, Gallagher EJ. Reliability of the visual analog scale for measurement of acute pain. Acad Emerg Med. 2001 Dec;8(12):1153-7. doi: 10.1111/j.1553-2712.2001.tb01132.x.

  PMID: 11733293 BACKGROUND

• Bodian CA, Freedman G, Hossain S, Eisenkraft JB, Beilin Y. The visual analog scale for pain: clinical significance in postoperative patients. Anesthesiology. 2001 Dec;95(6):1356-61. doi: 10.1097/00000542-200112000-00013.

  PMID: 11748392 BACKGROUND

• Chaillet N, Belaid L, Crochetiere C, Roy L, Gagne GP, Moutquin JM, Rossignol M, Dugas M, Wassef M, Bonapace J. Nonpharmacologic approaches for pain management during labor compared with usual care: a meta-analysis. Birth. 2014 Jun;41(2):122-37. doi: 10.1111/birt.12103. Epub 2014 Apr 25.

  PMID: 24761801 BACKGROUND

• Dencker A, Taft C, Bergqvist L, Lilja H, Berg M. Childbirth experience questionnaire (CEQ): development and evaluation of a multidimensional instrument. BMC Pregnancy Childbirth. 2010 Dec 10;10:81. doi: 10.1186/1471-2393-10-81.

  PMID: 21143961 BACKGROUND

• Jones L, Othman M, Dowswell T, Alfirevic Z, Gates S, Newburn M, Jordan S, Lavender T, Neilson JP. Pain management for women in labour: an overview of systematic reviews. Cochrane Database Syst Rev. 2012 Mar 14;2012(3):CD009234. doi: 10.1002/14651858.CD009234.pub2.

  PMID: 22419342 BACKGROUND

• Lang AJ, Sorrell JT, Rodgers CS, Lebeck MM. Anxiety sensitivity as a predictor of labor pain. Eur J Pain. 2006 Apr;10(3):263-70. doi: 10.1016/j.ejpain.2005.05.001. Epub 2005 Jun 28.

  PMID: 15987671 BACKGROUND

• Myles PS. The pain visual analog scale: linear or nonlinear? Anesthesiology. 2004 Mar;100(3):744; author reply 745. doi: 10.1097/00000542-200403000-00042. No abstract available.

  PMID: 15108996 BACKGROUND

• Smith CA, Levett KM, Collins CT, Jones L. Massage, reflexology and other manual methods for pain management in labour. Cochrane Database Syst Rev. 2012 Feb 15;(2):CD009290. doi: 10.1002/14651858.CD009290.pub2.

  PMID: 22336862 BACKGROUND

• Soriano-Vidal FJ, Oliver-Roig A, Cabrero-Garcia J, Congost-Maestre N, Dencker A, Richart-Martinez M. The Spanish version of the Childbirth Experience Questionnaire (CEQ-E): reliability and validity assessment. BMC Pregnancy Childbirth. 2016 Nov 24;16(1):372. doi: 10.1186/s12884-016-1100-z.

  PMID: 27884123 BACKGROUND

• WHO recommendations: Intrapartum care for a positive childbirth experience. Geneva: World Health Organization; 2018. Available from http://www.ncbi.nlm.nih.gov/books/NBK513809/

  PMID: 30070803 BACKGROUND

• Hamidzadeh A, Shahpourian F, Orak RJ, Montazeri AS, Khosravi A. Effects of LI4 acupressure on labor pain in the first stage of labor. J Midwifery Womens Health. 2012 Mar-Apr;57(2):133-8. doi: 10.1111/j.1542-2011.2011.00138.x. Epub 2012 Mar 2.

  PMID: 22432484 RESULT

• Rosseland LA, Reme SE, Simonsen TB, Thoresen M, Nielsen CS, Gran ME. Are labor pain and birth experience associated with persistent pain and postpartum depression? A prospective cohort study. Scand J Pain. 2020 Jul 28;20(3):591-602. doi: 10.1515/sjpain-2020-0025.

  PMID: 32469334 RESULT

• Sehhatie-Shafaie F, Kazemzadeh R, Amani F, Heshmat R. The effect of acupressure on sanyinjiao and hugo points on labor pain in nulliparous women: a randomized clinical trial. J Caring Sci. 2013 Jun 1;2(2):123-9. doi: 10.5681/jcs.2013.015. eCollection 2013 Jun.

  PMID: 25276718 RESULT

• Smith CA, Levett KM, Collins CT, Dahlen HG, Ee CC, Suganuma M. Massage, reflexology and other manual methods for pain management in labour. Cochrane Database Syst Rev. 2018 Mar 28;3(3):CD009290. doi: 10.1002/14651858.CD009290.pub3.

  PMID: 29589380 RESULT

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Emine Nur Çalımlı Celep

  Researcher Assistant

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 4, 2023
• First Posted: October 30, 2023
• Study Start: April 30, 2020
• Primary Completion: June 30, 2020
• Study Completion: December 30, 2020
• Last Updated: October 30, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)