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

NCT ID: NCT06106867

Last Updated: 2023-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-30

Study Completion Date

2020-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Labor Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental Group

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.

Group Type EXPERIMENTAL

External pressure to the palm

Intervention Type 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.

Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Emine Nur Çalımlı Celep

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Emine Nur Çalımlı Celep

Role: PRINCIPAL_INVESTIGATOR

Researcher Assistant

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Istanbul University-Cerrahpasa

Istanbul, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 29680213 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30575638 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11733293 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11748392 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24761801 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21143961 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22419342 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15987671 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15108996 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22336862 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27884123 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 30070803 (View on PubMed)

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.

Reference Type RESULT
PMID: 22432484 (View on PubMed)

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.

Reference Type RESULT
PMID: 32469334 (View on PubMed)

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.

Reference Type RESULT
PMID: 25276718 (View on PubMed)

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.

Reference Type RESULT
PMID: 29589380 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IUC-ENC

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Effect of Reflexology on Labor
NCT03877302 COMPLETED NA