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Labor PainNCT06106867

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

A study testing External pressure to the palm in people with Labor Pain, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for
Labor Pain
What is being tested?
External pressure to the palm
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
30 Apr 2020to 30 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Istanbul University-Cerrahpasa

    Istanbul, 34500

Other trials in Turkey (Türkiye)

About this study

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.

Read the detailed 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.

Conditions
Labor Pain
Being tested
External pressure to the palm
Keywords
external pressure, labor pain, childbirth experience, non-pharmacological method, midwifery care
Medical subject headings
Labor Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • External pressure to the palmProcedure or surgery

    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.

Study groups in NCT06106867
Study groupRoleWhat they receive
Experimental GroupExperimentalInformation 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.
Receives: Procedure: External pressure to the palm
Control GroupNo interventionRoutine midwifery care and services applied to all pregnant women in the hospital were provided to the participants in the control group.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    (min:0, max:10)

    Measured: 30 minutes

  2. The Childbirth Experience Questionnaire (CEQ)

    Measured: At the 30th minute postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2023
  2. Study start30 Apr 2020
  3. Primary completion30 Jun 2020
  4. Study completion30 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06106867
Sponsor's protocol ID
IUC-ENC
Status last verified
Oct 2023
First submitted
4 Oct 2023
Last updated
30 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29680213

  • 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.

    PubMed 30575638

  • 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.

    PubMed 11733293

  • 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.

    PubMed 11748392

  • 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.

    PubMed 24761801

  • 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.

    PubMed 21143961

  • 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.

    PubMed 22419342

  • 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.

    PubMed 15987671

  • 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.

    PubMed 15108996

  • 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.

    PubMed 22336862

  • 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.

    PubMed 27884123

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

    PubMed 30070803

  • 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.

    PubMed 22432484

  • 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.

    PubMed 32469334

  • 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.

    PubMed 25276718

Questions about this trial

What is this clinical trial studying?

A study testing External pressure to the palm in people with Labor Pain, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analogue Scale (VAS) Level of labor pain will be measured with VAS. (time frame: 30 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06106867, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2023.

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