Protocol summary

Summary
1) Objectives: This randomized clinical trial study has been carried on 150 primi-parous women with mild to moderate anxiety who referred to selected medical-educational centers ( of Hafez & Shooshtari Hospitals ) of Shiraz University of Medical Sciences, comprising the effects of cupping therapy and acupressure In BL 23 Point on postpartum low back and perineal pain (LBPP). 2) Design: After informed consent, eligible patients were randomly assigned in to three groups: Cupping therapy, acupressure and control. As control group performance has not been observed by the researcher, she is allowed to use Acetaminophen.) 3) Setting and conduct: In the 1st interventional group, cupping therapy was done in at least 4 to 8 hours after childbirth in their postpartum part for every other day and four times a week (15-20 minutes per time). In the 2nd group, the researcher presses BL23 acupoint on both sides of the backbone symmetrically, for 20 minutes. Two times of interventions is done inpatient and last outpatient. 4)Participants) Inclusion criteria: 1) 18 - 40 years old; 2) Graduate School at least; 3) Lacking any of overt & Serious psycho-somatic diseases during the study such as: vertebral fractures, herniated disk, acute inflammation, deep vein thrombosis; 4) Mild to moderate anxiety; 5) Residents of shiraz; 6) Willingness to participate in research and complete consent form; 7) Low back pain only results from lordosis of pregnancy and childbirth deteriorating by fetous weight and position or labour in some mothers. Exclusion criteria: 1) Medical and obstetric complications in the postpartum during the study; 2) Not lookup for following at certain appointments; 3) Asking for exclusion; 4) Using of drugs for pain relief. 5) Intervention: Cupping therapy - acupressure 6) Main outcome measures variables): Patients filled out the VAS & Mc-Gill questionnaires as self-reports, in phases of once before, once immediately after, once 24 hours after and once 2 weeks after treatments.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012123011944N1
Registration date: 2013-07-17, 1392/04/26
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-07-17, 1392/04/26
Registrant information
Name
Mehrnoush Ghaemmaghami
Name of organization / entity
Faculty of Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3502
Email address
mehrnoushghmghm68@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Expected recruitment start date
2013-01-09, 1391/10/20
Expected recruitment end date
2013-02-08, 1391/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Cupping Therapy and Acupressure In BL 23 Point on Postpartum Low Back and Perineal Pain (LBPP) in Primiparous Women with Mild to Moderate Anxiety, Referred to Selected Medical-educational Centers of Shiraz University of Medical Sciences, in 2012
Public title
The Effect of Cupping Therapy and Acupressure on Postpartum Low Back and Perineal Pain
Purpose
Treatment
Inclusion/Exclusion criteria
Main inclusion criteria to study: 1) 18 - 40 years old; 2) Graduate School at least; 3) Lacking any of overt & Serious psycho-somatic diseases during the study such as: vertebral fractures, herniated disk, acute inflammation, deep vein thrombosis; 4) Mild to moderate anxiety; 5) Residents of Shiraz; 6) Willingness to participate in research and complete consent form; 7) Low back pain only results from lordosis of pregnancy and childbirth deteriorating by fetous weight and position or labour in some mothers. Main exclusion criteria from study: 1) Medical and obstetric complications in the postpartum during the study; 2) Not lookup for following at certain appointments; 3) Asking for exclusion; 4) Using of drugs for pain relief.
Age
From 18 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences Ethics Committee
Street address
7th floor, Central Building of Shiraz University of Medical Sciences, Zand Street, Shiraz, Fars Province, Iran, 1978 -71345
City
Shiraz
Postal code
1978 -71345
Approval date
2012-11-26, 1391/09/06
Ethics committee reference number
CT-91-6341

Health conditions studied

1

Description of health condition studied
low back pain
ICD-10 code
M54.5
ICD-10 code description
low back pain

2

Description of health condition studied
perineal pain
ICD-10 code
R10.2
ICD-10 code description
perineal pain

Primary outcomes

1

Description
low back pain
Timepoint
4-8 hours at least after childbirth
Method of measurement
VAS & Mc-Gill pain questionnaires

2

Description
perineal pain
Timepoint
4-8 hours at least after childbirth
Method of measurement
VAS & Mc-Gill pain questionnaires

Secondary outcomes

empty

Intervention groups

1

Description
In the 1st interventional group, cupping therapy is done in at least 4 to 8 hours of childbirth in their postpartum part for every other day and four times a week (15-20 minutes per time); 2 times of interventions were done inpatient and the last outpatient. In this study cupping is done in the mode of dry and hot blazing cotton dipped in alcohol inside the cup and warming it and right after, laying it on the surface of the patient's body. It is possible to apply cupping on BL23 for both low back and perineal pain.
Category
Treatment - Other

2

Description
In the 2nd group, researcher symmetrically presses BL23 acupoint on both sides of the backbone, by thumb finger for 5 minutes clockwise and 5 minutes counterclockwise. It lasts 20 minutes per-time. Two times of interventions are done inpatient and the last outpatient.
Category
Treatment - Other

3

Description
As control group performance has not been observed by the researcher, she is not allowed to use Acetaminophen. Finally the both types of treatments are presented to the patients through instructional classes or pamphlets.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Hafez Hospital
Full name of responsible person
Mohammadali Tadayon
Street address
Martyr Chamran Blvd, Shiraz, Fars
City
Shiraz

2

Recruitment center
Name of recruitment center
Shooshtari Hospital
Full name of responsible person
Andisheh Jorkesh
Street address
Bascule Nader- Shiraz
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Hatam
Street address
7th floor, Central Building of Shiraz University of Medical Sciences, Zand Street, Shiraz, Fars Province, Iran
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Marzieh Akbarzadeh
Position
Master of Midwifery
Other areas of specialty/work
Street address
Hazrat-e-Fatemeh nursing and midwifery college, Namazi Hospital, Namazi Square, Shiraz.
City
Shiraz
Postal code
71345-1978
Phone
+98 71 1647 4254
Fax
+98 71 1627 9135
Email
AKBARZADEHMARZIEH@YAHOO.COM
Web page address
www.sums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Marzieh Akbarzadeh
Position
Master of Midwifery
Other areas of specialty/work
Street address
Hazrat-e-Fatemeh nursing and midwifery college, Namazi Hospital, Namazi Square, Shiraz.
City
Shiraz
Postal code
71345- 1978
Phone
+98 71 1647 4254
Fax
+98 71 1627 9135
Email
AKBARZADEHMARZIEH@YAHOO.COM
Web page address
www.sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mehrnoush Ghaemmaghami
Position
Master of Midwifery
Other areas of specialty/work
Street address
Hazrat-e-Fatemeh nursing and midwifery college, Namazi Hospital, Namazi Square, Shiraz.
City
Shiraz
Postal code
71936 - 13119
Phone
+98 71164742548
Fax
+98 64 74252
Email
ghaem_m@sums.ac.irM.REGIA1368@YAHO.COMM.REGIA68@GMAIL.COM
Web page address
nurs-midwif.sums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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