Determining the effect of reflexology in reducing pain and anxiety of labor
Design
consecutive Clinical Trial study of multi-arm type randomized with one control and two intervention groups , on the 105 pregnant women without blinding. The random allocation was carried out by drawing lottery cards with tokens intervention1,2 and control group
Settings and conduct
The study was performed in the maternity ward of hospital in Firoozabad.The control group received routine care and in the two intervention groups, olive and lavender oil respectively were used for reflexology for 20 minutes for foot . Reflexology was performed at one time in 4-5 cm dilatation . Then, for the intervention and control groups, the pain and anxiety questionnaires were completed again in dilatation of 4-5 cm (immediately after the intervention) and 7-8 cm.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Primiparous mothers with full-term and single pregnancies with cephalic presentation who don't use analgesics to reduce pain.
Exclusion criteria: History of miscarriage and high risk pregnancy
Intervention groups
the control group : routine maternity cares (control of contractions, fetal heart rate, monitoring labor progress and no palliative drug interventions), for the intervention group 1: routine cares along with using Reflexology technique of trigger points of Sole with non-aromatic oil (Olive oil) and the intervention group 2: routine cares along with Reflexology of trigger points of Sole with aromatic oil (Lavender oil).pressure at points of solar grid (at the border of the upper and middle third of the sole), pituitary point and uterus (between the inner ankle and the heel) was continued for a period of 20 minutes for each foot. Reflexology was taken place at one time in 4-5 cm dilatation.
Main outcome variables
Pain; anxiety; duration of the first and second stages of labor ; apgar score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200810048357N1
Registration date:2020-10-05, 1399/07/14
Registration timing:retrospective
Last update:2020-10-05, 1399/07/14
Update count:0
Registration date
2020-10-05, 1399/07/14
Registrant information
Name
Farzaneh Farahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3720 5444
Email address
frznfarahi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-18, 1398/04/27
Expected recruitment end date
2020-02-19, 1398/11/30
Actual recruitment start date
2019-07-18, 1398/04/27
Actual recruitment end date
2020-02-19, 1398/11/30
Trial completion date
2020-02-19, 1398/11/30
Scientific title
Comparing the effect of foot trigger reflexology with aromatherapy on anxiety, pain and consequences of labor pregnancy in women
Public title
Effect of reflexology on reducing labor pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
primigravida mothers having single term pregnancy with cephalic presentation
The least dilatation of 4-5cm (the beginning of active phase of delivery
No medical problems or pregnancy and fetal complications
Without applying Analgesics and Anesthetics,
Possessing psychical and cognitive ability to cooperate
Having informed consent for participation
Exclusion criteria:
Miscarriage history
High risk pregnancy
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
105
Actual sample size reached:
99
Randomization (investigator's opinion)
Randomized
Randomization description
Each mother was allocated randomly to one of the intervention or control groups. The random sampling was performed by drawing 105 cards labeled as intervention1,intervention 2 and control equally from a matte box .Thus the random sequence was not predictable.
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
Ethics committee of Kazeroon Islamic Azad University
Street address
Shahid Ghasem soleimani Blvd., Kazeroon azad university
City
Kazeroon
Province
Fars
Postal code
7319866451
Approval date
2019-07-16, 1398/04/25
Ethics committee reference number
IR.IAU.KAU.REC.1398.060
Health conditions studied
1
Description of health condition studied
Labor pain
ICD-10 code
O75.8
ICD-10 code description
Other specified complications of labor and delivery
Primary outcomes
1
Description
Labor pain
Timepoint
Pain were measured before intervention and then after intervention in 4- 5 and 7- 8 cm dilatation
Method of measurement
Visual analogue scale
2
Description
Anxiety
Timepoint
Anxiety was measured before intervention and then after intervention in 4-5 and 7-8 cm dilation
Method of measurement
Spielberger questionnaire
Secondary outcomes
1
Description
Apgar score
Timepoint
Immediately after birth
Method of measurement
Using the Apgar score table
2
Description
Duration of the first stage of labor
Timepoint
Measure the time between dilatations 4-10 cm
Method of measurement
Time measurement
3
Description
Duration of the second stage of labor
Timepoint
From dilatation 10 cm to delivery
Method of measurement
Time measurement
Intervention groups
1
Description
intervention group 1 : Routine cares along with reflexology technique of trigger points of sole with non-aromatic oil (olive oil)was continued for a period of 20 minutes for each foot. Reflexology with olive oil was taken place at one time in 4-5 cm dilatation
Category
Treatment - Other
2
Description
Intervention group2: Routine cares along with Reflexology technique of trigger points of Sole with aromatic oil (Lavender oil)was continued for a period of 20 minutes for each foot. Reflexology with Lavender oil was taken place at one time in 4-5 cm dilatation
Category
Treatment - Other
3
Description
Control group: routine maternity cares (control of contractions, fetal heart rate, monitoring labor progress, and no sedative drug interventions) performed Throughout the labor.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Sajad Ahmadi
Street address
Pasdaran Ave ; Shahid Chegini blvd
City
Firoozabad
Province
Fars
Postal code
7471841313
Phone
+98 71 3872 7091
Email
firoozabadhp@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ghareh Daghy Hossein
Street address
Islamic Azad University Ave; Baseaj Square
City
Firoozabad
Province
Fars
Postal code
7471913113
Phone
+98 71 3872 9701
Email
gharehdaghy80@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Farzaneh Farahi
Position
Faculty
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
14 Alley , Shareefabad Ave
City
Shiraz
Province
Fars
Postal code
7157874696
Phone
+98 71 3720 5444
Email
frznfarahi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farzaneh Farahi
Position
Faculty
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Alley 14 , Shareefabad Ave
City
Shiraz
Province
Fars
Postal code
7157874696
Phone
+98 71 3720 5444
Email
frznfarahi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farahi Farzaneh
Position
Faculty
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Alley 14 , Shareefabad Ave
City
Shiraz
Province
Fars
Postal code
7157874696
Phone
+98 71 3720 5444
Email
frznfarahi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Only part of the data that is related to the main outcome and is electronic will be available via e-mail after authentication and eligibility of the applicants.
When the data will become available and for how long
One year after the publication of the article and for one year the data will become available.
To whom data/document is available
Researchers and academics in universities
Under which criteria data/document could be used
Only systematic review and meta-analysis of data will be possible
From where data/document is obtainable
Call the number 0098 9367088289. Farahi farzaneh
What processes are involved for a request to access data/document
Having sufficient explanations and clarify their purpose for data analysis. additionaly presenting a formal request from a research institute or university.