The Effect of Acupressure on Labor Pain and Anxiety Levels During Labor in Primiparas Women

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

Study Overview

• Status: Completed
• Conditions: Labor Pain
• Intervention / Treatment: Procedure: acupressure; Procedure: sham acupressure

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 17452
    • Faculty of physical therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 30 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: acupressure; 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; 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.
SHAM_COMPARATOR: sham acupressure	Procedure: sham acupressure; Pressures were applied on sham points consecutively

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
pulse rate response	will measured using pulse oximetry	about one hour
blood pressure response	will measured using sphygmomanometer	about one hour

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 7, 2022
• Primary Completion (ACTUAL): July 8, 2022
• Study Completion (ACTUAL): July 15, 2022

Study Registration Dates

• First Submitted: June 6, 2022
• First Submitted That Met QC Criteria: June 6, 2022
• First Posted (ACTUAL): June 9, 2022

Study Record Updates

• Last Update Posted (ACTUAL): November 29, 2022
• Last Update Submitted That Met QC Criteria: November 23, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain
• Other Study ID Numbers: P.T.REC/012/003704

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No