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The effect of TENS on the severity of pain during medical abortion in the first trimester of pregnancy in comparison with the control group

Protocol summary

Study aim
1.Comparison of two groups for pain intensity at the time of starting use of TENS and at 2, 4, 6, 8 and 10 hours after using TENS and at the time of abortion 2. Comparison of two groups for satisfaction of the process of analgesia 3. Comparison of two groups for satisfaction of the process of abortion 4. Comparison of two groups for satisfaction of using of TENS 5. Comparison of two groups for medical abortion success 6. Comparison of two groups for side effects 7. Comparison of two groups for amount of ibuprofen consumption
Design
Clinical Trial, with two parallel groups, triple blind, randomized, phase 2 with 60 patients. The order of the patients was questioned from an external source who identified the sequence by the block randomized method.
Settings and conduct
Back ground: First trimester abortion, Taleghani and Akbar Abadi Hospitals, Clinical trial, Triple blind: Researcher, Analyzer, Patients
Participants/Inclusion and exclusion criteria
Inclusion criteria: Pregnant women with gestational age less than 13 weeks according to LMP and ultrasound who are candidate for medical abortion with misoprostol. Excluding criteria: Allergy to misoprostol and ibuprofen, Drug addiction, History of chronic pain, History of using TENS.
Intervention groups
Intervention group: Pregnant women candidate for pregnancy termination with misoprostol in the first trimester who take Ibuprofen and TENS for analgesia. Control group: Pregnant women candidate for pregnancy termination with misoprostol in the first trimester who take ibuprofen for analgesia.
Main outcome variables
Pain during hospitalization, pain when starting to use TENS, pain at 2, 4, 6, 8 and 10 hours after starting to use TENS Satisfaction of abortion process, satisfaction of analgesia, satisfaction of TENS, amount of Ibuprofen used, success of abortion, side effects

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170515033989N2
Registration date: 2021-11-17, 1400/08/26
Registration timing: registered_while_recruiting

Last update: 2021-11-17, 1400/08/26
Update count: 0
Registration date
2021-11-17, 1400/08/26
Registrant information
Name
Minoo Yaghmaei
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2590
Email address
m.yaghmaei@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-01, 1400/08/10
Expected recruitment end date
2022-11-21, 1401/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of TENS on the severity of pain during medical abortion in the first trimester of pregnancy in comparison with the control group
Public title
The effect of TENS on the severity of pain during medical abortion pain in the first trimester of pregnancy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Single pregnancy Less than 13 weeks of pregnancy Body mass index below 30 kg / m2 Candidate for termination of pregnancy with Misoprostol
Exclusion criteria:
Sensitivity to Misoprostol and Ibuprofen Drug addiction History of chronic pain History of using TENS
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization of block: There will be twelve blocks, each block containing 5 units. For randomization statistical software will be used and the result will provided to a person outside the research group. For each patient who meets the including, this person will be contacted and she will announce the group (control or case).
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, TENS device is connected to both case and control groups, however, it is active in the case group and inactive in the control group. The person who fills in the questionnaire and records the outcomes, as well as the researcher who collects the information and the person who performs the analysis, are blind to the membership of participants.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Taleghani Hospital, Arabi st., Daneshjoo Blv, Shahriari sq., Evin
City
Tehran
Province
Tehran
Postal code
1985717418
Approval date
2021-09-18, 1400/06/27
Ethics committee reference number
IR.SBMU.RETECH.REC.1400.266

Health conditions studied

1

Description of health condition studied
Medical Abortion
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Ibuprofen intake
Timepoint
Once at the end of the abortion process
Method of measurement
Dosage consumed throughout the abortion process (mg)

2

Description
pain
Timepoint
At the beginning of hospitalization - at the beginning of using TENS - at 2, 4, 6, 8 and 10 hours after TENS
Method of measurement
Numeral Visual scale (NVS)

3

Description
Satisfaction with the whole abortion process
Timepoint
Once the abortion process is completed
Method of measurement
Based on the question from the patient - bad - normal - good - excellent

4

Description
Satisfaction with the analgesia process
Timepoint
Once the abortion process is completed
Method of measurement
Based on the question from the patient - bad - normal - good - excellent

5

Description
Satisfaction with the use of the TENS device
Timepoint
Once the abortion process is completed
Method of measurement
Based on the question from the patient - bad - normal - good - excellent

6

Description
Duration of use of TENS
Timepoint
Once the abortion process is completed
Method of measurement
Minute

7

Description
Side effects
Timepoint
Once the abortion process is completed
Method of measurement
Question from the patient and examination and mention of the complication

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Using TENS and Ibuprofen to reduce pain in first trimester abortion candidates with misoprostol - Ibuprofen administration method: Ibuprofen Tab ( produced by Loghman Pharmaceuticals) 200 mg (in case of moderate pain) or 400 mg (in case of severe pain). TENS (HMB-1000 TENS, South Korea) : Four pads are placed two in the lower abdomen and two in the waist area, which is connected to the device with a wire. TENS is set at a frequency of 80 Hz with an intensity of 0 to 80 (according to the patient's wishes).
Category
Treatment - Devices

2

Description
Control group: Use of unbound TENS (placebo) and ibuprofen to reduce pain in first trimester abortion candidates with misoprostol - Method of administration of ibuprofen tablet (produced by Loghman Pharmaceuticals) 200 mg (in case of moderate pain) or 400 mg (in case of Severe pain). In this group, four TENS pads (HM-1000, made in South Korea) are placed two in the lower abdomen and two in the waist area, but the connection wire between the pad and the device is not connected.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Minoo Yaghmaei
Street address
Taleghani Hospital, Erabi street, Daneshjoo Blv, Shahriari sq, Evin
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2243 2560
Email
m.yaghmaei@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Vice President for Research and Technology
Street address
Taleghani Hospital, Erabi street, Daneshjoo Blv, Shahriari sq, Evin
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2243 2560
Email
m.yaghmaei@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Minoo Yaghmaei
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Taleghani Hospital, Erabi street, Daneshjoo Blv, Shahriari sq, Evin
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2243 2560
Email
m.yaghmaei@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Minoo Yaghmaei
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Taleghani Hospital, Erabi street, Daneshjoo Blv, Shahriari sq, Evin
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2243 2560
Email
m.yaghmaei@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Minoo Yaghmaei
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Taleghani Hospital, Arabi st., Daneshjoo Blv, Shahriari sq., Evin
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2243 2560
Email
m.yaghmaei@sbmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is available on demand after being unidentifiable
When the data will become available and for how long
Up to six months from the publication of the results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Mention a valid request from the applicant
From where data/document is obtainable
Dr. Minoo Yaghmaei m.yaghmaei@sbmu.ac.ir
What processes are involved for a request to access data/document
Must be emailed.
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