Protocol summary

Study aim
Determining the effect of communication skills training program on the quality of father-girl relationship and coping with menstrual complaints in adolescent girls
Design
In this study, 60 people (30 fathers and 30 girls with premenstrual syndrome and dysmenorrhea) are enrolled in the study.These people are selected from among two high schools, one high school is allocated to the intervention group and another high school to the control group.
Settings and conduct
At first, the participants in the demographic and menstrual profile and the premenstrual syndrome screening tool (PSST) were filled out by the participating girls and they were randomly divided into two intervention and control groups. Next, in the intervention group, qualified fathers will receive education, During the workshop, Effective communication skills of father-daughter will be taught. In this study, the Parent-Child Relationship Questionnaire (PCRS), Pre-menstrual Coping Measure and Menstrual Coping Questionnaire completed before, immediately, four weeks and eight weeks after the intervention by the girls.
Participants/Inclusion and exclusion criteria
Students of a single teenage girl between the ages of 15 and 18 years old and their fathers; Diagnosis of premenstrual syndrome or dysmenorrhea in three cycles of menstruation; Fathers and daughters have not lived apart, nor have they been step father and daughter.
Intervention groups
Intervention group: Before the intervention, the intervention group will be given brochures containing information about the knowledge of psychological coping with premenstrual syndrome and dysmenorrhea. In the intervention group, after completing the questionnaires, communication skills education to their fathers will be provided in during a one-day workshop. Effective communication skills are taught through participatory learning techniques, discussions, lectures, questions and answers, group activities and role-play. Education will be carried out by a person who is skillful in communication. Workshop content involves teaching concepts such as communication, communication skills, communication process, the importance of communication, verbal communication and non-verbal communication, components of communication, effective communication, concepts and goals of active listening, effective listening techniques, effective communication barriers, effective communication strategies and methods for more effective verbal communication, communication during conflict, negative relationships between parents and adolescents and how to avoid negative relationships, with emphasis on the relationship between father and daughter will be taught. The research team members will be available to answer their questions and resolve any ambiguity. Control group: before the intervention, the control group will be given brochures containing information about the knowledge of psychological coping with premenstrual syndrome and dysmenorrhea. In the control group, their girls and their fathers receive no training.
Main outcome variables
The results of this research will be useful in developing adolescent fertility prevention and health education about menstruation complaints of adolescent girls by improving their life skills and applying them to research on reproductive health in adolescents.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170114031930N1
Registration date: 2017-11-28, 1396/09/07
Registration timing: registered_while_recruiting

Last update: 2017-11-28, 1396/09/07
Update count: 0
Registration date
2017-11-28, 1396/09/07
Registrant information
Name
Sahar Rekab
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 4244 2140
Email address
saharsepideh70@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice-Chancellor for Research and Technology, Iran University of Medical Sciences
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2019-02-19, 1397/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Communication Skills Education Program on Quality of Parent-Daughter Relationship and Coping with Menstrual Complaints Among Adolescent Girls
Public title
The Effect of Communication Skills Education Program on Quality of Parent-Daughter Relationship and Coping with Menstrual Complaints Among Adolescent Girls
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Single female students (15-18 years old) and their fathers Diagnosis of premenstrual syndrome or dysmenorrhea in three cycles of menstruation Having a regular menstrual cycle (the duration of bleeding in the menstrual cycle is 7-10 days with a 28-33 days interval between two menstrual cycles) Fathers and daughters have not lived apart, nor have they been step father and daughter Father and mother live together Fathers and daughters have not used psychiatric medications for the last 6 months Having no mother with depression Not taking oral contraceptive pills for the last 6 months No specific physical and mental illnesses in fathers and daughters No severe life crises such as death and divorce in the last three months
Exclusion criteria:
Immigration and lack of access to the samples The occurrence of any chronic or severe mental or physical illness The occurrence of any crisis in the individual life (occurrence of death in the first degree relatives, parents’ divorce or severe family disputes)
Age
From 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method in this study is a binary random block.
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 Iran University of Medical Sciences"
Street address
Campus of Iran University of Medical Sciences, next to Milad Tower, Hemmat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2016-08-03, 1395/05/13
Ethics committee reference number
IR.IUMS.REC1395.9311373016

Health conditions studied

1

Description of health condition studied
Premenstrual syndrome
ICD-10 code
N94.3
ICD-10 code description
Premenstrual tension syndrome

2

Description of health condition studied
Dysmenorrhea
ICD-10 code
N94.4
ICD-10 code description
Primary dysmenorrhoea

Primary outcomes

1

Description
Parent-child relationship quality
Timepoint
Before, immediately, four weeks, eight weeks after the intervention
Method of measurement
Parent-Child Relationship Scale Questionnaire (PCRS)

2

Description
Premenstrual syndrome
Timepoint
Before, immediately, four weeks, eight weeks after the intervention
Method of measurement
PSST Questionnaire and Pre-menstrual Coping measure (PMCM)

3

Description
Special communication skills training
Timepoint
Before, immediately, four weeks, eight weeks after the intervention
Method of measurement
Training to a one-day workshop is held in the form of a speech, role play, film, etc.

4

Description
Duration of bleeding
Timepoint
Before intervention
Method of measurement
Demographic questionnaire

5

Description
The amount of menstrual bleeding
Timepoint
Before intervention
Method of measurement
Demographic questionnaire

6

Description
Menstrual cycle duration
Timepoint
Before intervention
Method of measurement
Demographic questionnaire

7

Description
Regular bleeding courses
Timepoint
Before intervention
Method of measurement
Demographic questionnaire

8

Description
Pain during menstruation
Timepoint
Before intervention
Method of measurement
Demographic questionnaire

Secondary outcomes

1

Description
Parent-child relationship quality
Timepoint
Before, immediately, four weeks, eight weeks after the intervention
Method of measurement
Parent-Child Relationship Scale Questionnaire (PCRS)

2

Description
Premenstrual syndrome
Timepoint
Before, immediately, four weeks, eight weeks after the intervention
Method of measurement
PSST Questionnaire and Pre-menstrual Coping measure (PMCM)

3

Description
Dysmenorrhea
Timepoint
Before, immediately, four weeks, eight weeks after the intervention
Method of measurement
Demographic questionnaire

Intervention groups

1

Description
Control group: before the intervention, the control group will be given brochures containing information about the knowledge of psychological coping with premenstrual syndrome and dysmenorrhea. In the control group, their girls and their fathers receive n
Category
Lifestyle

2

Description
Intervention group: Before the intervention, the intervention group will be given brochures containing information about the knowledge of psychological coping with Menstrual complaints. After completing the questionnaires, communication skills education
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Education Center of District 3 of Tehran
Full name of responsible person
Fatemeh sadiq
Street address
Education Management in District 3 of Tehran, Valiasr Ave., Vanak Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1996714953
Phone
+98 21 8482 1118
Email
tehran@tedu.ir
Web page address
http://tehranedu.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Seyed Kazem Malekoti
Street address
Campus of Iran University of Medical Sciences, next to Milad Tower, Hemmat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 2503
Email
research@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Sahar Rekab
Position
MSc Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Iran Nursing and Midwifery Faculty, Rashid Yasemi St., Vali-e-Asr Ave., Vanak Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Fax
Email
saharsepideh70@gmail.com
Web page address
http://fnm.iums.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Nahid Akbari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
PHD in reproductive health
Street address
Iran Nursing and Midwifery Faculty, Rashid Yasemi St., Vali-e-Asr Ave., Vanak Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Fax
Email
akbari1420@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Sahar Rekab
Position
MSc Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Iran Nursing and Midwifery Faculty, Rashid Yasemi St., Vali-e-Asr Ave., Vanak Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Fax
Email
saharsepideh70@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
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