Protocol summary

Summary
The aim of this study is to compare the effects of coping strategies and relaxation techniques on stress, Leiomyoma size and Leiomyoma symptoms. It is a randomized controlled clinical trial (not blinded) on 126 patients with uterine Leiomyoma : Inclusion criteria (Leiomyoma 1-7 cm; mild or moderate stress; age 20-45 years; body mass index less than 25; not taking drugs influential the Leiomyoma and stress; and not participating in yoga classes or other programs affecting stress). We will put qualified individuals randomly in three groups, each group consisting of 42 Patient. In the intervention group 1, will be held 6 sessions of coping strategies, within three weeks (two 90-minute sessions per week) . Class content includes: accepting the position؛ define the problem؛ brain storming solutions؛ make decisions؛ plan to implement the best solution؛ implementing the selected solution؛ evaluation of the results of the implementation of the solution؛ what are emotions؛ need of emotional management skills؛ obstacles of emotions management؛ cognitive sadness management). In groups 2, will be held a relaxation training session, and then they will be asked to do relaxation (once a day) at home for a month. The control group will not receive any treatments. Stress will be measured before intervention, 1 and 2 months after starting intervention in all three groups. The Leiomyoma size and Leiomyoma symptoms (bleeding, pelvic pain, urinary frequency and urgency of urination) will be measured before intervention and 2 months after the starting intervention in all three groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016121331387N1
Registration date: 2017-01-13, 1395/10/24
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-01-13, 1395/10/24
Registrant information
Name
Seyedeh Soheila Mohsenipoor
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 4252 3636
Email address
stud2392201821@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-02-19, 1394/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the training effects of Coping Strategies and Relaxation on Stress intensity of women who had Uterine Leiomyoma referred to Shiraz Gynecology Clinics-2015
Public title
The training effect of coping strategies and relaxation on stress treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 20 to 45 years; evidence of vaginal ultrasound of Uterine Leiomyoma (size 1-7 cm); have mild or moderate stress based on the DASS questionnaires; body mass index below 25; not taking any hormones affecting the size of the leiomyoma from start up to a month after the intervention; not taking any effective drug on stress and depression from start up to a month after the intervention; lack of medical conditions including hypertension, thyroid and diabetes; signing a consent form a conscious; non-participation in any classes or programs affecting stress such as relaxation, yoga and meditation. Exclusion criteria: use of any drug affecting the leiomyoma and stress during the intervention and one month after its completion; the patient's unwillingness to continue to work; absence in more than one session.
Age
From 20 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 126
Randomization (investigator's opinion)
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
Vice-Chancellor for Research, Shiraz University of Medical Sciences, Ethics Committee
Street address
Vice-Chancellor for Research, Shiraz University of Medical Sciences, Zand Blvd
City
Shiraz
Postal code
71345-1978
Approval date
2015-06-21, 1394/03/31
Ethics committee reference number
IR.SUMS.REC.1394.41

Health conditions studied

1

Description of health condition studied
Leiomyoma of uterus
ICD-10 code
D25.9
ICD-10 code description
Leiomyoma of uterus, unspecified

Primary outcomes

1

Description
Stress
Timepoint
Before the intervention, one and two months after starting intervention
Method of measurement
DASS standard questionnaire

2

Description
Leiomyoma size
Timepoint
Before and two months after starting intervention
Method of measurement
Vaginal ultrasound

3

Description
The Volume of Menstrual Bleeding
Timepoint
Before and two months after starting intervention
Method of measurement
Number of daily pad

4

Description
Pelvic Pain
Timepoint
Before and two months after starting intervention
Method of measurement
VAS

5

Description
Urinary Frequency
Timepoint
Before and two months after starting intervention
Method of measurement
Patient reports

6

Description
Urgency of Urination
Timepoint
Before and two months after starting intervention
Method of measurement
Patient reports

Secondary outcomes

empty

Intervention groups

1

Description
In the intervention group 1, will be held 6 sessions of coping strategies, within three weeks (two 90-minute sessions per week). Class content includes: the reception of Position; Problem Definition; brain storming solutions; Decision making; planning to implement the best solution; implementing the selected solution; evaluating the results of the implementation of the solution; what are emotions; need of emotional management skills; Barriers to manage emotions; Cognitive manage of emotions; Negative emotional management strategies ( management of Anger, anxiety and sadness).
Category
Behavior

2

Description
In groups 2, will be held beginning a training session relaxation, then will be asked the people to do relaxation once a day for a month at home.
Category
Behavior

3

Description
There is no intervention for control group
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shiraz Hafez Hospital
Full name of responsible person
Seyedeh Soheila Mohsenipoor(Masters Student)
Street address
Chamran Blvd
City
Shiraz

2

Recruitment center
Name of recruitment center
Hazrat Zeinab Hospital
Full name of responsible person
Seyedeh Soheila Mohsenipoor(Masters Student)
Street address
Zeinabiyeh Blvd
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-Chancellor for Research, Shiraz University of Medical Sciences
Full name of responsible person
Dr Seyed Basir Hashemi
Street address
Vice-Chancellor for Research, Shiraz University of Medical Sciences, Zand Blvd, Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellor for Research, Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Azam Jokar
Position
Master of Midwifery,Faculty Member
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Namazi Square, Zand Blvd
City
Shiraz
Postal code
71345-1978
Phone
+98 71 3647 4255
Fax
Email
jokarhs@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Azam Jokar
Position
Master of Midwifery, Faculty Member
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Namazi Square, Zand Blvd
City
Shiraz
Postal code
Phone
+98 71 3647 4255
Fax
Email
jokarhs@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Azam Jokar
Position
Master of Midwifery, Faculty Member
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Namazi Square, Zand Blvd
City
Shiraz
Postal code
Phone
+98 71 3647 4255
Fax
Email
jokarhs@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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