Back to resultsThe Effect of Acupressure on Labor Pain and Anxiety Levels During Labor in Primiparas Women
Primary Purpose
Labor Pain
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
acupressure
sham acupressure
Sponsored by
About this trial
This is an interventional supportive care trial for Labor Pain
Eligibility Criteria
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
Sites / Locations
- Faculty of physical therapy
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
acupressure
sham acupressure
Arm Description
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)
Outcomes
Primary Outcome Measures
Anxiety level
To measure anxiety, the Spiberger inventory questionnaire will be used
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
Secondary Outcome Measures
pulse rate response
will measured using pulse oximetry
blood pressure response
will measured using sphygmomanometer
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05411289
Brief Title
The Effect of Acupressure on Labor Pain and Anxiety Levels During Labor in Primiparas Women
Official Title
The Effect of Acupressure on Labor Pain and Anxiety Levels During Labor in Primiparas Women
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
June 7, 2022 (Actual)
Primary Completion Date
July 8, 2022 (Actual)
Study Completion Date
July 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
the effect of acupressure on labor pain and anxiety levels during labor in primiparas women
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
acupressure
Arm Type
Experimental
Arm Description
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)
Arm Title
sham acupressure
Arm Type
Sham Comparator
Intervention Type
Procedure
Intervention Name(s)
acupressure
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
sham acupressure
Intervention Description
Pressures were applied on sham points consecutively
Primary Outcome Measure Information:
Title
Anxiety level
Description
To measure anxiety, the Spiberger inventory questionnaire will be used
Time Frame
about one hour
Title
labor pain
Description
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
Time Frame
about one hour
Secondary Outcome Measure Information:
Title
pulse rate response
Description
will measured using pulse oximetry
Time Frame
about one hour
Title
blood pressure response
Description
will measured using sphygmomanometer
Time Frame
about one hour
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Faculty of physical therapy
City
Cairo
ZIP/Postal Code
17452
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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The Effect of Acupressure on Labor Pain and Anxiety Levels During Labor in Primiparas Women
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