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

Labor Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06106867
• Other study ID #: IUC-ENC
• Status: Completed
• Phase: N/A
• Start date: April 30, 2020
• Est. completion date: December 30, 2020

Study information

• Verified date: October 2023
• Source: Istanbul University - Cerrahpasa (IUC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Labor pain adversely affects pregnant women's perception of the labor process and childbirth. When not taken under control, it causes pregnant women to have negative experiences about the labor process and consequently leads to a decrease in their satisfaction with childbirth. For this reason the study was carried out to evaluate the effect of external pressure applied to the palm on labor pain and childbirth experience. Hypotheses of the research; H 1 : External pressure applied to the palm during labor reduces the level of labor pain. H 1 : External pressure applied to the palm during labor increases the positive birth experience.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Labor Pain

Intervention

Procedure:
• External pressure to the palm
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.

Locations

Country	Name	City	State
Turkey	Istanbul University-Cerrahpasa	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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-20 — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale (VAS) Level of labor pain will be measured with VAS.	(min:0, max:10)	30 minutes
Primary	The Childbirth Experience Questionnaire (CEQ)		At the 30th minute postpartum