The aim of this study is to determine the effect of foot reflexology on anxiety, pain and labor outcomes in primiparous women. This study is randomized controlled trial, one-blind and multi-center with two groups. The study populations include primiparous women with singleton term pregnancies with cephalic presentation and without any medical problems or pregnancy complications. They don’t use any drug or method of analgesia and anesthesia and labor induction. The sample include 50 patients (two groups of 25 persons) will be randomly allocated into the following two group: experimental group (foot reflexology) and control group (routine care). Intervention in reflexology group is consist gentle massage of plantar and then continuous pressure on solar network, pituitary and uterus points in the feet for 40 minutes (20 minutes per foot) at 3-4 cm dilatation. For the control group will be done routine care and massages of other parts of foot. Assessment of pain in the first stage of labor will be done in 3-4cm cervical dilatation, immediately after intervention and also the half-intervals, one and two hours after the intervention in two groups according to the McGill Pain index. Immediately after the intervention, Spielberger Anxiety Inventory is completed for intervention and control groups. Duration of the first, second and third stages of labor, type of delivery and neonatal Apgar score at 1 and 5 minutes after birth in both groups will be recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201103015948N1
Registration date:2011-06-24, 1390/04/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-06-24, 1390/04/03
Registrant information
Name
Soheila Moghimi Hanjani
Name of organization / entity
Islamic Azad University Karaj Branch
Country
Iran (Islamic Republic of)
Phone
+98 21 7720 4224
Email address
soheila.moghimi@kiau.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Islamic Azad University of karaj branch
Expected recruitment start date
2011-06-08, 1390/03/18
Expected recruitment end date
2011-09-09, 1390/06/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of foot reflexology on anxiety, pain and outcomes of labor in primiparus woman referred to the Karaj hospital in 2011
Public title
The effect of foot reflexology on labor outcome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Women with singleton pregnancies and fetal with cephalic presentation, gestational age 37-41 weeks, without active psychiatric disorders and anxiety on personality according to Beck and Spielberger questionnaires, without mental retardation, blindness and deafness, absence of fever, seizures, thrombosis, renal or gallbladder stones, foot disease, swelling, ulcer, trauma and fractures in the foot, not using the anti-anxiety medications and methods of complementary medicine during the previous week.
Exclusion criteria: Use of any drug or method of analgesia and anesthesia, induction of labor with Oxytocin, abnormal fetal heart patterns, presence of any special medical condition (e.g. chronic diseases) and nature of taking any drug, women with a history of abortion, gestational hypertension, presence of any abnormal bleeding from placental abruption or placenta previa, polyhydroamnious, oligohydroamnious and intrauterine growth restriction that proved by ultrasound method, passing more than 12 hours from the time of rupture of membrane.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Islamic Azad university Karj barnch
Street address
Crossroad of Moazen Blv and Esteghlal Blv, Rajaeeshahr, Karaj, Mailbox: 31485-313
City
Karaj
Postal code
Approval date
2011-06-07, 1390/03/17
Ethics committee reference number
0022
Health conditions studied
1
Description of health condition studied
Labor outcomes
ICD-10 code
O80-O84
ICD-10 code description
Delivery
Primary outcomes
1
Description
Labor pain intensity
Timepoint
Before intervention in 3-4cm cervical dilatation and immediately, half, one and two hours after the intervention
Method of measurement
McGill pain questionnaire
2
Description
Anxiety score
Timepoint
Before intervention in 3-4cm cervical dilatation and immediately after the intervention
Method of measurement
Spielberger anxiety inventory
3
Description
Duration of the first stage of labor
Timepoint
One time the start of labor until complete effacement and cervical dilatation
Method of measurement
According to minutes using the standard digital clock
4
Description
Duration of the second stage of labor
Timepoint
One time from full dilatation of cervix to departure of baby
Method of measurement
According to minutes using the standard digital clock
5
Description
Duration of the third stage of labor
Timepoint
One time from departure of baby to complete withdrawal of placenta
Method of measurement
According to minutes using the standard digital clock
Secondary outcomes
1
Description
Type of delivery
Timepoint
One time after departure of baby
Method of measurement
Observed as a vaginal delivery, instrumental delivery and cesarean section
2
Description
Apgar score
Timepoint
At 1 and 5 minutes after birth
Method of measurement
Observation and examination
Intervention groups
1
Description
For intervention group: Gentle massage of all surface of plantar and some points upon of feet using thumb and pointing fingers then continuous pressure on solar network, pituitary and uterus points in the feet for 40 minutes (20 minutes per foot) at 3-4 cm dilatation. The point of solar network is located on the border of one-third upper and middle feet (in part that wrinkle is formed during the foot plantar flexion) along the second and third finger. Pituitary point is located in the middle of toe. Uterine point also is located into the deep area between internal ankles and heel of feet.
Category
Other
2
Description
For control group: Receiving routine care of labor ward and massages of other parts of foot except three main points that mentioned, for 40 minutes (20 minutes per foot) at 3-4 cm dilatation.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Alborz hospital
Full name of responsible person
Zahra Mehdizadeh Toorzani
Street address
Alborz hospital, Parastar Blv, Western Baghestan, Mianjadeh, Karaj