The results of this study may lend support to reliving postpartum pain by using reflexology as a replacement or supplement of analgesics.
Design
The participants of this study that is a clinical treatment, will be 68 eligible postpartum women (34 in the reflexology group and 34 in the control group) referring to the Department of Obstetrics of Razi Hospital of Ahvaz. Sampling will be done using randomized blocks of four
Settings and conduct
The study will be conducted at Razi Hospital of Ahvaz. Sixty-eight women whose afterpains score is moderate and severe (3.1-10) will be selected and divided into two groups of control and intervention using randomized blocks of four. The intervention group will receive reflexology for both feet for 20 min on the intended points while the control group will receive only the routine care.
Participants/Inclusion and exclusion criteria
Inclusion criteria
1. Spontaneous vaginal delivery
2. Singleton pregnancy
3. Cephalic presentation
4 . Mother's complaint of moderate or severe postpartum pain (a pain score of 3.1 or above based on Visual Analogue Scale)
5. Age between 18-35
6. Second to fourth parity
Exit criteria
1. Hard and prolonged delivery
2. Mother's substance abuse
3. Postpartum hemorrhage
4. Underlying illnesses (blood pressure, diabetes, kidney problem, etc.)
5. Any problem with the soles such as corns, burns, cuts, fungal infection, varicose veins, warts or any numbness in the foot
6. Still births
Intervention groups
In the intervention group, 34 eligible women will receive reflexology at certain points in their feet. The control group will receive only the routine care.
Main outcome variables
Postpartum afterpains, the severity of afterpains, duration of afterpains
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171208037792N1
Registration date:2018-07-14, 1397/04/23
Registration timing:retrospective
Last update:2018-07-14, 1397/04/23
Update count:0
Registration date
2018-07-14, 1397/04/23
Registrant information
Name
galiya bakhtiyari niya
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3222 3747
Email address
galiyabakhtiyari21@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-04, 1397/01/15
Expected recruitment end date
2018-06-05, 1397/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of foot reflexology on reduction post partum after pain
Public title
The effect of foot reflexology on reduction post partum after pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Natural childbirth
Being semicolon
Single baby
Cephalic display
Approximate weight 2500-4000
Mother's complains of moderate or severe labor pain
Age 18-35
Second to fourth childbirth
Body mass index between 18.5-29.9
Exclusion criteria:
Hard and prolonged delivery
Mother drug addiction
History of postpartum hemorrhage
Background of the underlying disease
History of lesion in the leg
Stillbirth
Fetal Dead
Intense stress
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
Care provider
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling of the subjects and their grouping into control and intervention groups will be done using randomized blocks of four.
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 Ahvaz Jundishapur University of Medical Sciences and Health Services
Street address
Ahvaz Jundishapur University of Medical Sciences and Health Services ،Golestan BLV، Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2018-04-04, 1397/01/15
Ethics committee reference number
IR.AJUMS.REK.1396.494
Health conditions studied
1
Description of health condition studied
Post partuum After pain
ICD-10 code
Z39
ICD-10 code description
Encounter for maternal postpartum care and examination
Primary outcomes
1
Description
Post Partum After Pain (Pain score between middle and high)
Timepoint
Determining the severity of pain by Visual Analogue Scale(VAS) before and after the intervention, immediately after intervention,at minutes 30, 60, 120, and 6 hours after the intervention, and the duration of the pain in the interval between the onset of the intervention and the mild pain.
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
post partum afterpain
Timepoint
Determining the severity of pain by Visual Analogue Scale(VAS) before and after the intervention, immediately after intervention,at minutes 30, 60, 120, and 6 hours after the intervention, and the duration of the pain in the interval between the onset of the intervention and the mild pain
Method of measurement
Visual Analogue Scale
Intervention groups
1
Description
Intervention group: Reflexologylasting for 10 minutes at the points of interest on each leg. Pituitary, (behind the toes) Solar plexus (found by drawing an imaginary line from the third toe down to just below the ball of the foot) the inner arch of the foot and the uterus (the area between the ankles in the leg and the heel)
Category
Treatment - Other
2
Description
group: Massage of other parts of the foot or routine care
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Obstetrics and Gynecology, Ahvaz Razi Hospital
Full name of responsible person
Galiya Bakhtiari Nia
Street address
Ahvaz Amaniyeh Department of Obstetrics and Gynecology, Razi Hospital