Study of Applying Acupressure in Low-birth Weight Premature
Primary Purpose
Premature
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
acupressure
Sponsored by
About this trial
This is an interventional supportive care trial for Premature focused on measuring acupressure, very-low- birth-weight premature, body weight, behavioral state, developmental status
Eligibility Criteria
Inclusion Criteria:
- according to the criteria of very low birth weight (<1500gm) from a sick baby room in a medical center.
Exclusion Criteria:
- Exclusion criteria of very low birth weight (>1500gm) from a sick baby room in a medical center.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
experimental group
control group
Arm Description
The babies in experimental group will be observed for one day, and then intervene the simplified acupressure three times a day for fifteen days, and continuously recoding the observation and records until discharge.
The control group only receive routine care in sick baby room unite.
Outcomes
Primary Outcome Measures
Body Weight
The data will be collected by a self-developed structured questionnaire, including: 1) demographic data of premature; 2)body weight every day until discharge.
Secondary Outcome Measures
Full Information
NCT ID
NCT03061968
First Posted
January 12, 2011
Last Updated
February 22, 2017
Sponsor
Li-Li Chen
Collaborators
China Medical University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03061968
Brief Title
Study of Applying Acupressure in Low-birth Weight Premature
Official Title
Study of Appling Acupressure in Low-birth Weight Premature
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 2010 (Actual)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
February 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Li-Li Chen
Collaborators
China Medical University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to investigate the effects of acupressure application in very low birth weight premature.
Detailed Description
A quasi-experimental study is designed. Sixty premature babies will be recruited by purposed sampling, according to the criteria of very low birth weight (<1500gm) from a sick baby room in a medical center. The control group only receive routine care in sick baby room unite. The babies in experimental group will be observed for one day, and then intervene the simplified acupressure three times a day for 15 days, and continuously recoding the observation and records until discharge. The intervention includes acupressure for 15 minutes each at 10Am, 1Pm and 4Pm.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature
Keywords
acupressure, very-low- birth-weight premature, body weight, behavioral state, developmental status
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
experimental group
Arm Type
Experimental
Arm Description
The babies in experimental group will be observed for one day, and then intervene the simplified acupressure three times a day for fifteen days, and continuously recoding the observation and records until discharge.
Arm Title
control group
Arm Type
No Intervention
Arm Description
The control group only receive routine care in sick baby room unite.
Intervention Type
Behavioral
Intervention Name(s)
acupressure
Intervention Description
The babies in experimental group will be observed for one day, and then intervene the simplified acupressure three times a day for fifteen days, and continuously recoding the observation and records until discharge.
Primary Outcome Measure Information:
Title
Body Weight
Description
The data will be collected by a self-developed structured questionnaire, including: 1) demographic data of premature; 2)body weight every day until discharge.
Time Frame
15 days.
10. Eligibility
Sex
All
Maximum Age & Unit of Time
37 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
according to the criteria of very low birth weight (<1500gm) from a sick baby room in a medical center.
Exclusion Criteria:
Exclusion criteria of very low birth weight (>1500gm) from a sick baby room in a medical center.
12. IPD Sharing Statement
Plan to Share IPD
No
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Study of Applying Acupressure in Low-birth Weight Premature
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