Determining the effect of chewing gum on the severity of nausea and vomiting after hysteroscopic procedures
Design
Clinical trial with control group, parallel groups, single-blind, randomized with 52 patients
Settings and conduct
Participants are patients undergoing hysteroscopic surgery at Rasoul Akram and Firoozgar Hospitals. Participants will be randomly assigned to two groups. Outcome assessors will also not be aware of the type of intervention.
Participants/Inclusion and exclusion criteria
Enough teeth to chew gum; ASA 1-3; no phenylketonuria
Intervention groups
Intervention group: chewing gum without flavor.
Control group: Endosteron in the amount of 4 mg intravenously.
Main outcome variables
Nausea and vomiting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190929044924N2
Registration date:2020-07-07, 1399/04/17
Registration timing:registered_while_recruiting
Last update:2020-07-07, 1399/04/17
Update count:0
Registration date
2020-07-07, 1399/04/17
Registrant information
Name
Reza Farahmandrad
Name of organization / entity
Iran University Of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 8852 2083
Email address
farahmandrad.r@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2021-06-22, 1400/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of chewing gum on the severity of nausea and vomiting after hysteroscopic procedures
Public title
Chew gum on the severity of nausea and vomiting
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Enough teeth to chew gum
ASA 1-3
No phenylketonuria
Exclusion criteria:
No history of neuromuscular problems
smoking
Post operative nausea-vomitin (PONV )
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
The patients were randomly divided into intervention and control groups using a lottery method. As the names of all participants are placed inside the container. The names are drawn out from the container, respectively, and placed in the intervention and control groups. At the end, the papers containing the names are opened and different groups are determined.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and outcome assessors will not be aware of the type of intervention
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Next to Milad Tower, Hemat Highway ,Tehran
City
Tehran
Province
Tehran
Postal code
14496-14535
Approval date
2020-02-29, 1398/12/10
Ethics committee reference number
IR.IUMS.FMD.REC.1398.526
Health conditions studied
1
Description of health condition studied
Nausea and vomiting
ICD-10 code
R11.2
ICD-10 code description
Nausea with vomiting, unspecified
Primary outcomes
1
Description
Nausea and vomiting
Timepoint
15 minutes after starting treatment
Method of measurement
Ask the patient
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Participants are asked to continue chewing gum without flavor for at least 10 minutes. The chewing gum used will be the non-essence chewing gum of the FALIM Turkey Company.
Category
Treatment - Surgery
2
Description
Control group: Endosterone will be injected intravenously at a dose of 4 mg. Endosteron is produced by "َAlborz daro" company of Iran.