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The effect of melatonin on the sleep quality of patients with chronic pelvic pain caused by endometriosis, a triple-blind randomized controlled trial study in the provider unit

Protocol summary

Study aim
The effect of melatonin on the sleep quality of patients with chronic pelvic pain caused by endometriosis
Design
A triple blind parallel randomized controlled trial
Settings and conduct
In the run-in phase of the study medical student and gynecologist will be present at endometriosis clinic in the Fatemezahra infertility center 4 days in a week. All participants have an identifiable sleep disturbance by PSQI global score ≥5, followed by a confirmed diagnosis of chronic pelvic pain according to visual analog scale. Demographic characteristics and a complete medical history will be obtained at the initial visit as well as through a clinical interview including age, occupation, body mass index, pelvic pain intensity, medical and drug history, endometriosis pelvic ultrasound findings, and endometriosis laparoscopy findings. All eligible participants will be asked to sign a written informed consent. PSQI will be completed before and after 2 months of intervention.The drug and placebo are similar in terms of appearance, and the patients, the outcome assessor, and the statistician will be unaware of the allocation of the drugs.
Participants/Inclusion and exclusion criteria
• 18- 45 years of age, who had complained of endometriosis with EACPP, and Sleep disturbances based on PSQI questionnaire (score ≥ 5). • No history of surgical or medical treatments for infertility. • Not smoking, drinking alcohol, and addiction to substance. • Lack of systemic illness diseases, such as diabetes, blood pressure, seizures.
Intervention groups
Group A includes patients receiving melatonin and group B includes patients receiving placebo.
Main outcome variables
change in sleep quality according to (PSQI) questionnaire, endometriosis associated pelvic pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171209037794N4
Registration date: 2023-07-07, 1402/04/16
Registration timing: prospective

Last update: 2023-07-07, 1402/04/16
Update count: 0
Registration date
2023-07-07, 1402/04/16
Registrant information
Name
Parvaneh Mirabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8898 7958
Email address
parvaneh_mirabi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-16, 1402/04/25
Expected recruitment end date
2023-10-12, 1402/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of melatonin on the sleep quality of patients with chronic pelvic pain caused by endometriosis, a triple-blind randomized controlled trial study in the provider unit
Public title
melatonin and sleep quality
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The eligibility of each included patients will be confirmed by the gynecologist. Subjects eligible for the study must meet all of the following criteria at randomization: •18- 45 years of age, who had complained of endometriosis with EACPP, and Sleep disturbances based on PSQI questionnaire (score ≥ 5). •No history of surgical or medical treatments for infertility. •Not smoking, drinking alcohol, and addiction to substance. •Lack of systemic illness diseases, such as diabetes, blood pressure, seizures
Exclusion criteria:
•continuous use of sleeping pills, anticoagulants and anticonvulsants •women treated with antidepressants •use of stimulants or hypnotics or anti-anxiety medications •recent diagnosis of mood disorders or neuropsychiatric symptoms (within 8 weeks) • pregnancy or breastfeeding •known hypersensitivity to melatonin •If the patient does not want to continue to participation •Ongoing or previous pharmacologically treated depression or bipolar disorder •Work involving nightshifts
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted block randomization will be used to achieve balance in the allocation of participants to intervention arms. Before initiation of the run- in phase of the study, two 80- sets of random numbers will be created by a member of the research team not involved in recruitment. Twenty blocks with size of 4 and combination of A for the melatonin and B for placebo group will be prepared. A randomization will be made by using a dedicated online software (http://www.randomization.com). Allocation sequence will be password-protected and only accessible to the independent investigator not involved in the study.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Administration of medication type will be triple-blinded. The patient, the outcome assessor and the statistical analyst will be blinded. Blinding of medication conditions will be conducted by a pharmacist at Shahid Beheshti University of Medical Sciences. Placebo capsules will be lactose and cellulose and will be identical in size and appearance to the melatonin capsule (Jalinous Pharmaceutical Company).
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Ganj Afrooz
City
Babol
Province
Mazandaran
Postal code
47176-47745
Approval date
2023-07-03, 1402/04/12
Ethics committee reference number
MUBABOL.HRI.REC.1402.041

Health conditions studied

1

Description of health condition studied
Endometriosis
ICD-10 code
N80
ICD-10 code description
Endometriosis

Primary outcomes

1

Description
sleep quality
Timepoint
Before and 2 months after intervention
Method of measurement
PSQI-19 questionnaire

Secondary outcomes

1

Description
pelvic pain
Timepoint
Before and two months after the intervention
Method of measurement
VAS score

Intervention groups

1

Description
Intervention group: patients will receive 5 mg melatonin tablet once a day for 2 months.
Category
Treatment - Drugs

2

Description
Control group: patients will receive placebo once a day for 2 months.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Fatemezahra infertility center
Full name of responsible person
parvaneh mirabi
Street address
Gang Afrooz
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3219 0558
Email
parvaneh_mirabi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
mehdi rajabnia
Street address
Ganj Afrooz
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3219 7667
Email
ramazan69@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
parvaneh mirabi
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
infertility and reproductive health
Street address
Ganj Afrooz
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3219 0558
Email
parvaneh_mirabi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
parvaneh_mirabi
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Ganj Afrooz
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 0558
Email
parvaneh_mirabi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
parvaneh mirabi
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Ganj Afrooz
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 0558
Email
parvaneh_mirabi@yahoo.com

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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Data on the main outcome will be available
When the data will become available and for how long
Access period starts 6 months after the publication of results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
It's not specified yet.
From where data/document is obtainable
Dr Parvaneh Mirabi parvaneh_mirabi@yahoo.com
What processes are involved for a request to access data/document
Two weeks after application
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