1. Home
  2. Approved trials
  3. » فارسی

The effect of reflexology on pain intensity and duration of labor in primipar women.

Protocol summary

Summary
Introuduction: Excessive pain can lead to the aggravation of mothers’ fear and anxiety, and subsequently decrease uterine contractions and increase labor time and the probability of aided delivery and Caesarean Section. Pain control is an important part of modern Midwifery care, and in addition to pharmacological methods of pain relief, reflexology is used as a non-drug, non-invasive technique. This study aimed to investigate the effects of reflexology on pain intensity and duration of labor. Methods: In this clinical trial, 240 Iranian primipara women with singleton gestations, age group of 18-35 years, with gestational age of 37-42 weeks, cephalic presentation fetus, no infertility background and caesarian indications, intended pregnancy, no medical or delivery problem attested by gynecologists, lack of applying analgesia and anesthesia during labor, a dilatation of 3-4 cm. The participant were selected using a convenient sampling method and randomly divided into two groups. In intervention group reflexology was performed for 20 minutes (10 minutes per leg) during the active phase of labor and uterine contractions. In control group the same was done, except that a point other than the uterine point was given a massage. Pain intensity during the active phase of labor (3-4, 5-7 and 8-10 cm dilatation ) and duration of active phase of labor were measured and compared in two groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014043017503N1
Registration date: 2014-07-08, 1393/04/17
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-07-08, 1393/04/17
Registrant information
Name
Azita Kamjoo
Name of organization / entity
Hrmozgan
Country
Iran (Islamic Republic of)
Phone
+98 76 1666 6367
Email address
a.kamjoo@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
Hormozgan University Of Medical Science"
Expected recruitment start date
2012-05-30, 1391/03/10
Expected recruitment end date
2013-12-31, 1392/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of reflexology on pain intensity and duration of labor in primipar women.
Public title
The effect of reflexology on pain intensity and duration of labor in primipar women.
Purpose
Other
Inclusion/Exclusion criteria
Iranian primipara women with singleton gestations, age group of 18-35 years, with gestational age of 37-42 weeks, cephalic presentation fetus, no infertility background and caesarian indications, intended pregnancy, no medical or delivery problem attested by gynecologists, lack of applying analgesia and anesthesia during labor, a dilatation of 3-4 cm.
Age
From 18 years old to 34 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 240
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
"Hormozgan university of medical sciences"
Street address
bandarabbas-chamran street
City
Bandarabbas
Postal code
Approval date
2012-05-22, 1391/03/02
Ethics committee reference number
HEC-93-1-24-5

Health conditions studied

1

Description of health condition studied
Spontaneous vertex delivery
ICD-10 code
O80.0
ICD-10 code description
single spontaneous delivery

Primary outcomes

1

Description
intensity and duration of labour
Timepoint
20 minitspost intervention
Method of measurement
Visual analuge scale

Secondary outcomes

empty

Intervention groups

1

Description
In the intervention group, once the 4 centimeter dilatation was began, a mild massage was done on the whole surface of the foot. It was followed by a massage of the reflexive spot for pain reduction which is a curving area between the ankle and the heel. It is called the uterine area. It received a 10-min massage in each foot (20 mins all together). Once contractions began, the massage would also begin and once the contractions were over, the message was over too. The frequency of massages depended on the frequency of contractions during that 20 minuts.
Category
Other

2

Description
In the control group, a similar process was followed; however, a spot other than the uterine spot was massaged. It received a 10-min massage in each foot (20 mins all together). Once contractions began, the massage would also begin and once the contractions were over, the message was over too. The frequency of massages depended on the frequency of contractions during that 20 minuts.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shariaty Hospital
Full name of responsible person
azita kamjoo
Street address
City
Bandarabbas

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
'Hormozgan Universiy Of Medical Sciences
Full name of responsible person
Azita Kamjoo
Street address
Chamran Streets, Bandarabbas
City
Bandarabbas
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
'Hormozgan Universiy 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
Hormozgan Unhversity Of Medical Sciences
Full name of responsible person
Azita Kamjoo
Position
Master Of Mid wifery
Other areas of specialty/work
Street address
Bandarabbas Resalat streets Nursing and Midwifery Faculty
City
Bandarabbas
Postal code
Phone
+98 76 1666 6367
Fax
Email
azita.kamjoo@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
"Hormozgan University Of Sciences"
Full name of responsible person
Azita kamjoo
Position
Master of midwifery
Other areas of specialty/work
Street address
Bandarabbas - resalat Streeti-nursing and-midwifery faculty
City
Bandarabbas
Postal code
Phone
+98 76 1666 6367
Fax
Email
azita.kamjoo@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
"Hormozgan University Of Sciences"
Full name of responsible person
Azita kamjoo
Position
Master of midwifery
Other areas of specialty/work
Street address
Bandarabbas- nursing and midwifery faculty
City
Bandarabbas
Postal code
Phone
00
Fax
Email
Web page address

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
Loading...