NCT05411289

Brief Summary

the effect of acupressure on labor pain and anxiety levels during labor in primiparas women

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 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

First Submitted

Initial submission to the registry

June 6, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

June 7, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 9, 2022

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2022

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2022

Completed
Last Updated

November 29, 2022

Status Verified

November 1, 2022

Enrollment Period

1 month

First QC Date

June 6, 2022

Last Update Submit

November 23, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Anxiety level

    To measure anxiety, the Spiberger inventory questionnaire will be used

    about one hour

  • labor pain

    labor pain will be assessed using visual analogue scale. . It employs a 10-cm ruler scale with no pain sign at one end and the most intense pain sign at the other to allow users to assess their own pain

    about one hour

Secondary Outcomes (2)

  • pulse rate response

    about one hour

  • blood pressure response

    about one hour

Study Arms (2)

acupressure

EXPERIMENTAL

Pressures were applied on three points consecutively, firstly on two points bilaterally Hugo point (LI4) and He-7 (Shenmen), then pressure was applied on sanyinjiao (SP6)

Procedure: acupressure

sham acupressure

SHAM COMPARATOR
Procedure: sham acupressure

Interventions

acupressurePROCEDURE

Pressures were applied on three points consecutively, firstly on two points bilaterally Hugo point (LI4) and He-7 (Shenmen), then pressure was applied on sanyinjiao (SP6). pressure was applied gradually for 30 seconds on the above mentioned points. Then this pressure was slowly intensified to the extent that the patient felt tingling, numbness, heaviness, and strain in the surrounding area.

acupressure

Pressures were applied on sham points consecutively

sham acupressure

Eligibility Criteria

Age20 Years - 30 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Primiparas women aged from 20 to 30 years old,
  • gestational age of between 37 and 40 weeks according to ultrasonography.
  • A fetal weight of between 2500 and 3500 g according to ultrasonography or clinical examination .
  • They are transferred to labor room if active labor is in progress (defined as cervical dilatation 3 cm and the presence of regular uterine contraction,
  • having a single and healthy fetus in the vertex position

You may not qualify if:

  • who were needing an emergency C-section.
  • Women having a current or previous high-risk pregnancy
  • who have experienced pregnancy complications
  • Women with a systemic disease during pregnancy . Women with a psychological disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical therapy

Cairo, 17452, Egypt

Location

Related Publications (1)

  • Hasanin ME, Elsayed SH, Taha MM. Effect of Acupressure on Anxiety and Pain Levels in Primiparous Women During Normal Labor: A Randomized Controlled Trial. J Integr Complement Med. 2024 Jul;30(7):654-661. doi: 10.1089/jicm.2023.0072. Epub 2023 Dec 20.

MeSH Terms

Conditions

Labor Pain

Interventions

Acupressure

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
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

June 6, 2022

First Posted

June 9, 2022

Study Start

June 7, 2022

Primary Completion

July 8, 2022

Study Completion

July 15, 2022

Last Updated

November 29, 2022

Record last verified: 2022-11

Locations