The aim of this study is Comparison of the effect of auriculotherapy (ear acupressure) and foot reflexology (reflexology massage) on pain and anxiety after cesarean section. The inclusion criteria include singleton pregnancy; Labor pains not start; The elective cesarean section planned before the onset of labor; No Medical condition in mother (cardiac, respiratory, hepatic or neurologic); using Spinal analgesia for caesarean section; No addiction to drugs, sedatives and alcohol in mother. Exclusion criteria include uncomfortable feel in ear acupressure or foot massage; complications during and after surgery such as prolonged duration of surgery, excessive bleeding and fetal death.
This clinical trial will be done in Omolbanin Hospital in Mashhad. 132 pregnant women eligible for selection and after obtaining write consent randomly divide into three groups (auriculotherapy, foot reflexology and control). reflexology or auriculotherapy perform for 20 minutes ,at 2 - 3 hours after injection of anesthetic. one and two hours after the intervention the pain and anxiety ,by the McGill Pain Questionnaire and Spielberger questionnaire, evaluate. In the control group only at this time the pain and anxiety evaluate. In all three groups ,at the request of the patient's, routine analgesics used and its will be recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014122920475N1
Registration date:2015-11-06, 1394/08/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-11-06, 1394/08/15
Registrant information
Name
Razieh Joghataei
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 4562 2849
Email address
joghataeir911@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
90 prcent Mashhad University of Medical Sciences , 10 percent Evidence-based research center
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-01-21, 1394/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of foot reflexology and Auriculotherapy on pain and anxiety in women following elective cesarean section
Public title
Comparison of the effect of ear acupressure and foot reflexology on pain and anxiety in women following elective cesarean section
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria include singleton pregnancy; gestational age more than 37 weeks; Labor pains not start; The elective cesarean section planned before the onset of labor; using Spinal analgesia for caesarean section; No Medical condition in mother (cardiac, respiratory, hepatic or neurologic); normal body mass index (18.5< BMI <30) in first trimester of pregnancy; lack of injuries and wounds at the feet or ears; no history of migraine; no History of foot reflexology or Auriculotherapy; No addiction to drugs, sedatives and alcohol in mother.
Exclusion criteria:
uncomfortable feel in ear acupressure or foot massage; Lack of cooperation from the study; the cesarean incision is not transverse; complications during and after surgery such as excessive bleeding , adhesions, fetal death and prolonged duration of surgery(more than 1 hour).
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:
132
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
Mashhad University of Medical Sciences
Street address
Avenue next to the cinema Hoveizeh- Mashhad Medical Sciences- Department of Science and Technology
City
Mashhad
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
IR.MUMS.REC.1394.261
Health conditions studied
1
Description of health condition studied
Cesarean pain and anxiety
ICD-10 code
o82
ICD-10 code description
single delivery by caesarean section
Primary outcomes
1
Description
pain
Timepoint
2-3Hours after anesthetic injection - 2 and 3 hours after Intervention
Method of measurement
McGill pain questionnaire-Visual Analogue Scale
2
Description
Anxiety
Timepoint
3-2 hours after injection of anesthetic- One and two hours after the intervention.
Method of measurement
Anxiety Inventory Spielberger
Secondary outcomes
1
Description
Nausea -Bloodshed
Timepoint
One and two hours after the intervention.
Method of measurement
Nausea visual analogue scale
2
Description
Bloodshed
Timepoint
One and two hours after the intervention.
Method of measurement
Weighing pads soaked in blood
Intervention groups
1
Description
foot reflexology prformed in the first intervention group. Reflexology intervention performed once for 20 minutes in both legs 2-3 hours after injecting anesthetic for spinal anesthesia.
Category
Behavior
2
Description
In the control group does not take action
Category
N/A
3
Description
in the second intervention group Auriculotherapy performed once for 20 minutes in both ears.