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

• Sponsor: Cairo University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05411289
• Collaborator: (none)
• Enrollment: 60
• Arms: 2
• Anticipated Duration (Months): 1.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Labor Pain	Procedure: acupressure; Procedure: sham acupressure	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: The Effect of Acupressure on Labor Pain and Anxiety Levels During Labor in Primiparas Women
• Anticipated Study Start Date: Jun 7, 2022
• Anticipated Primary Completion Date: Jul 8, 2022
• Anticipated Study Completion Date: Jul 15, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Anxiety level [about one hour]

   To measure anxiety, the Spiberger inventory scale will be used

2. labor pain [about one hour]

   labor pain will be assessed using visual analogue scale

Secondary Outcome Measures

1. pulse rate response [about one hour]

   will measured using pulse oximetry

2. blood pressure response [about one hour]

   will measured using sphygmomanometer

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 30 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mona Mohamed Taha, Assistant professor, Cairo University
• ClinicalTrials.gov Identifier: NCT05411289
• Other Study ID Numbers: P.T.REC/012/003704
• First Posted: Jun 9, 2022
• Last Update Posted: Jun 9, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Labor Pain

Study Results

No Results Posted as of Jun 9, 2022