There are various methods to reduce labor pain; one of the most intense forms of pain. Natural methods could diminish usage of different types of analgesic methods during delivery and provide mother calmness. Hypnosis is a noninvasive method that could decline pain, fear, and anxiety. Therefore we aimed to evaluate the effectiveness of hypnosis on normal vaginal delivery (NVD) pain.
Design
A controlled non-randomized, non-blinded, clinical trial with a parallel group on 45 patients
Settings and conduct
All pregnant women with good hypnotizability and were candidate for first NVD between September 2018 and May 2020 were trained hypnosis. In delivery room, these inductions were applied by a trained midwife on pregnant mothers without using any medicine, anesthetic or analgesic methods. Pregnant mothers who received 25-50 milligrams intravenous Pethidine during delivery in this time period were considered as intravenous analgesic group. Also pregnant mothers who used neither analgesic nor anesthetic method were recruited as physiologic group. All deliveries were done in Mashhad, Bentolhoda Hospital with equivalent care.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Pregnant women are candidates for the first NVD
Exclusion criteria: Pregnant women with pregnancy related diseases
Intervention groups
Hypnosis group: Pregnant women who were trained delivery pleasing inductions and pain control conditioning since 32th week of pregnancy, in three 30-minute sessions at intervals of 3 weeks. In delivery room, these inductions were applied by a trained midwife on pregnant mothers without using any other analgesic methods.
Physiologic group: Pregnant mothers who received neither analgesic nor anesthetic drugs for delivery.
Intravenous analgesic group: Pregnant mothers who received Pethidine during delivery.
Main outcome variables
Labor pain, anxiety, depression, fear
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200802048271N1
Registration date:2020-10-02, 1399/07/11
Registration timing:retrospective
Last update:2020-10-02, 1399/07/11
Update count:0
Registration date
2020-10-02, 1399/07/11
Registrant information
Name
Zahra Valipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3882 1691
Email address
valipourz911@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2020-06-20, 1399/03/31
Actual recruitment start date
2018-08-23, 1397/06/01
Actual recruitment end date
2020-06-20, 1399/03/31
Trial completion date
2020-06-20, 1399/03/31
Scientific title
Evaluation of the effectiveness of self-hypnosis in pain relief during labor in pregnant women
Public title
Effect of hypnosis in pain relief during childbirth in pregnant women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women who are candidate for the first vaginal delivery
Pregnant women who had good hypnotic induction profile
Exclusion criteria:
History of gestational diabetes
History of intrauterine growth restriction (IUGR)
History of any comorbidities in current pregnancy
History of previous vaginal delivery
Use of neuraxial blocking agents during delivery
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
45
Randomization (investigator's opinion)
Not 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
Ethics committee of Medical faculty of Mashhad University of Medical Sciences
Street address
Imam Reza Hospital, Imam Reza Sq., Ibn-e Sina Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Approval date
2019-01-22, 1397/11/02
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1397.775
Health conditions studied
1
Description of health condition studied
Normal vaginal delivery
ICD-10 code
O80
ICD-10 code description
Encounter for full-term uncomplicated delivery
Primary outcomes
1
Description
Labor pain
Timepoint
Immediately after delivery
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
State and trait anxiety
Timepoint
One month after delivery
Method of measurement
Spielberger State-Trait Anxiety questionnaire
2
Description
Post-partum depression
Timepoint
One month after delivery
Method of measurement
Edinburgh Postnatal Depression Scale
3
Description
Fear of delivery
Timepoint
Immediately after delivery
Method of measurement
Visual Analogue Scale
4
Description
Delivery method satisfaction
Timepoint
Immediately after delivery
Method of measurement
Visual Analogue Scale
Intervention groups
1
Description
Intervention group 1: Pregnant women who were candidate for first vaginal delivery and had a good hypnotizability were recruited to hypnosis group. Pregnant mothers were trained for hypnosis since 32th week of pregnancy, in three 30-minute sessions (once in every 3 weeks) and delivery pleasing inductions and pain control conditioning were done for them. In delivery room, these inductions were applied by a trained midwife on pregnant mothers without using medicine or other analgesic and anesthetic methods.
Category
Other
2
Description
Intervention group 2: Pregnant women who were candidate for first vaginal delivery and received 25-50 milligrams (depending on patient weight on the basis of 1milligram for each kilogram of patient weight with at least 25 mg and at-most 50 mg) Pethidine (Iran, Broujerd, EXIR) during delivery to alleviate pain, were recruited in intravenous analgesic group.
Category
Treatment - Drugs
3
Description
Control group: Pregnant women who experienced their first vaginal delivery without any analgesic or anesthetic drugs.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Bent Al-Hoda Hospital
Full name of responsible person
Mohammad Reza Amirhasankhani
Street address
Bahar St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9174685157
Phone
+98 51 3859 0051
Fax
+98 51 3851 8115
Email
bentolhodahospital@yahoo.com
Web page address
http://www.bent-hospital.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice research, Ghoreshi Building, Daneshgah St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresraech@mums.ac.ir
Grant name
Grant code / Reference number
970785
Is the source of funding the same sponsor organization/entity?