NCT06057116

Brief Summary

This research was conducted in accordance with the experimental research design to determine the effect of acupuncture and massage, which are non-pharmacological methods used in the treatment of labor pain, on the latent, active and transition stages of the first stage of labor. On labor pain and birth satisfaction. Burhan Nalbantoğlu State Hospital and Near East Hospital. There are three groups in the research sample: acupuncture, massage and control groups. A total of 66 people were reached, 22 people in each group. Massage and acupuncture were applied to the intervention groups, while pregnant women in the control group were not intervened other than routine hospital practices. Cervical dilatation was applied for 3-4, 5-7 and 8-10 cm, and massage was applied for 10 minutes each, for a total of 30 minutes. When cervical dilatation was 3-4, 5-7 and 8-10 cm, acupressure was applied for 1 minute each. The pain level perceived by the pregnant woman was evaluated with the Visual Comparison Scale (VAS), and her satisfaction with the birth was evaluated with the Birth Satisfaction Scale (DME). In comparing the Birth Satisfaction Scale scores and Postpartum Pain VAS Scores, the normal distribution of the data was examined with the Kolmogorov-Smirnov test, Shapiro-Wilk test and skewness-kurtosis values and it was determined that it showed a normal distribution, ANOVA was applied. Tukey test was used in further analysis for comparisons. ANCOVA was applied to compare the amount of pain changes at the beginning and end of the latent, active and transition phases according to participant groups.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 28, 2023

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

8 months

First QC Date

August 26, 2023

Last Update Submit

September 21, 2023

Conditions

Keywords

Massageacupressurelabor painbirth satisfaction

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Skala-VAS

    The VAS is a 10 cm long ruler drawn horizontally or vertically with the words "no pain" at one end and "unbearable pain" at the other end.

    1 year

Secondary Outcomes (1)

  • Birth Satisfaction Scale

    1 year

Study Arms (3)

massage

EXPERIMENTAL

Massage was applied to people who were hospitalized in the obstetrics ward of the pregnant woman, had a single fetus, awaiting spontaneous delivery, had no pregnancy complications, had no systemic disease, and agreed to voluntarily participate in the study.

Other: massage

acupressure

EXPERIMENTAL

Acupressure for pregnant women who are hospitalized in the obstetrics service, have a single fetus, expect spontaneous delivery, do not have pregnancy complications, do not have any systemic disease, and agree to voluntarily participate in the study.

Other: massage

control group

NO INTERVENTION

No intervention was performed on the patients who were hospitalized in the obstetrics service of the pregnant woman, had a single fetus, awaiting spontaneous delivery, had no pregnancy complications, had no systemic disease, and agreed to voluntarily participate in the study.

Interventions

massageOTHER

Massage and acupressure were applied when cervical dilatation was 3-4, 5-7 and 8-10 cm in latent active and transitional phases.

Also known as: Acupressure
acupressuremassage

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Çağla Taş

Adana, 99000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Labor Pain

Interventions

MassageAcupressure

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Investigator Midwife Çağla Taş

Study Record Dates

First Submitted

August 26, 2023

First Posted

September 28, 2023

Study Start

November 1, 2022

Primary Completion

June 15, 2023

Study Completion

June 15, 2023

Last Updated

September 28, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations