To determine the effect of foot reflexology on labor pain intensity and childbirth experience in primiparous women
Design
Clinical trial, with control group, with parallel groups, double blind, randomized
Settings and conduct
This randomized controlled clinical trial will be conducted in Al-Zahra and Taleghani hospitals of Tabriz. Participants will be divided into three groups by randomized blocking method and an assignment ratio of 1:1:1. The intervention group 1 will receive 30-minute reflexology twice at the effective pain point. The intervention group 2 will receive a 30-minute massage at the pain point and a 30-minute massage at the heel for each foot, and the control group will receive 30-minute massage at the heel twice for better blindness.
Participants/Inclusion and exclusion criteria
The participants will be nulliparous women with 38-42 weeks gestational age.
Intervention groups
The Intervention group will be intervention 1 (twice massage for 30 minutes at the effective point of pain for each foot), Intervention 2 (one 30 minutes massages at the effective point of pain, and one 30 minute massage on the heel for each foot) and control group (twice 30 minutes massage on the heels for each foot).
Main outcome variables
The main outcomes will be pain severity mean during labor and childbirth experience score.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120718010324N53
Registration date:2020-01-02, 1398/10/12
Registration timing:registered_while_recruiting
Last update:2020-01-02, 1398/10/12
Update count:0
Registration date
2020-01-02, 1398/10/12
Registrant information
Name
Mojgan Mirghafourvand
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6969
Email address
mirghafourvandm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-30, 1398/10/09
Expected recruitment end date
2020-06-19, 1399/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of foot reflexology on labor pain intensity and childbirth experience in primiparous women: a randomized controlled clinical trial
Public title
The effect of foot reflexology on pain intensity and child birth experience in primiparous women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
primiparous women
Gestational age 38-42 weeks
Singleton pregnancy
Cephalic presentation of the fetus
Intact amniotic sac
Having no history of infertility
Not having any physical or mental illness
No drug addiction
Low risk pregnancy (no third trimester bleeding, placental abruption, placenta previa, fetal developmental disorder, etc.)
No indication of cesarean section
No infection or obstruction at the massage site
No taking of drugs for pain relief up to 4 hours before intervention
Exclusion criteria:
Attending in reflexology classes
History of chronic systemic diseases including heart and pulmonary Diseases according to the patient statement.
Any skin disorders and bone fractures at the massage site
Receiving of analgesic medication (receiving epidural anesthesia and intravenous remifentanil infusion)
Receiving other non-pharmacological analgesics
Accelerated labor
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be assigned into three groups by block randomization method with block sizes of 3 and 6 and allocation ratio of 1:1:1 including intervention 1 (twice massage for 30-minutes at the effective point of pain for each foot), Intervention 2 (one 30-minutes massages at the effective point of pain, and one 30-minute massage on the heel for each foot), and control (twice 30-minutes massage on the heels for each foot). The allocation sequence will be determined by the person who is'n involved in the sampling and data collection.
Blinding (investigator's opinion)
Double blinded
Blinding description
The present study is a single-blind randomized controlled clinical trial (participant and data analyst will be unaware of the type of intervention received). Participants will be blinded by foot massage in all three group (at the effective point of pain or the heel of foot). Data analyses will be conducted by a person who will be unaware of the type of intervention received by groups and the groups will be categorized with letters of A, B and C.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz, East Azerbaijan
City
Tabriz
Province
East Azarbaijan
Postal code
00984113357311
Approval date
2019-11-24, 1398/09/03
Ethics committee reference number
IR.TBZMED.REC.1398.907
Health conditions studied
1
Description of health condition studied
Delivery
ICD-10 code
O80.0
ICD-10 code description
Spontaneous vertex delivery
Primary outcomes
1
Description
Pain severity during labor
Timepoint
Before the intervention and every hour during the active phase of labor
Method of measurement
Visual analog scale
2
Description
Childbirth experience
Timepoint
12 to 24 hours after delivery
Method of measurement
Labor Agency Scale
Secondary outcomes
1
Description
Duration of active phase of delivery
Timepoint
From dilatation 4 cm until full dilatation of cervix
Method of measurement
Partograph chart (minute)
2
Description
Duration of second stage of delivery
Timepoint
From full dilatation of cervix until birth of newborn
Method of measurement
Partograph chart (minute)
3
Description
Duration of Third stage of delivery
Timepoint
From birth of newborn until complete expulsion of placenta
Method of measurement
Partograph chart (minute)
Intervention groups
1
Description
The intervention group 1 will receive 30-minute reflexology twice at the effective pain point.
Category
Treatment - Other
2
Description
The intervention group 2 will receive a 30-minute massage at the pain point and a 30-minute massage at the heel for each foot.
Category
Treatment - Other
3
Description
The control group will receive 30-minute massage twice at the heel for each foot.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Educational and Treatment Center, Tabriz
Full name of responsible person
Masoumeh Ghameei Moghadam
Street address
Alzahra Educational and Treatment Center, South Artesh street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
۵۱۳۸۶۶۵۷۹۳
Phone
+98 41 3553 9163
Email
mjm.mid1373@gmail.com
2
Recruitment center
Name of recruitment center
Taleghani Educational and Treatment Center, Tabriz
Full name of responsible person
Masoumeh Ghameei Moghadam
Street address
Talegani hospital, Rah Ahan square, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5197615413
Phone
+98 41 3442 4425
Email
mjm.mid1373@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Samiei
Street address
Research department, third floor, central construction number 2, Tabriz medical science university, Golgasht Street, Azadi Avenue, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
mirghafourvandm@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Masoumeh Jameei Moghadam
Position
MSc student of Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing & Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
mjm.mid1373@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mojgan Mirghafourvand
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing & Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
mirghafourvandm@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mojgan Mirghafourvand
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing & Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
mirghafourvandm@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Participants data is confidential
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The results of clinical study will be published as article.
When the data will become available and for how long
Immediately after publishing the results.
To whom data/document is available
All researchers
Under which criteria data/document could be used
Scientific using with citation to article
From where data/document is obtainable
Email: mirghafourvandm@tbzmed.ac.ir
What processes are involved for a request to access data/document