| CTRI Number |
CTRI/2020/04/024538 [Registered on: 09/04/2020] Trial Registered Prospectively |
| Last Modified On: |
08/04/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
Effectiveness of Cognitive Behavioural Therapy on reducing the symptoms of Premenstrual syndrome |
|
Scientific Title of Study
|
A study to asess the effectiveness of Cognitive behavioural therapy on reducing the symptoms of premenstrual syndrome among nursing students in selected colleges of Ambala, Haryana. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vijaya Bharti |
| Designation |
M.Sc. Nursing |
| Affiliation |
M.M. COLLEGE OF NURSING |
| Address |
M.M College of Nursing , Mullana, Ambala, Haryana.
M.M College of Nursing , Mullana, Ambala, Haryana.
Ambala
HARYANA
136118
India |
| Phone |
7404101035 |
| Fax |
|
| Email |
vijaya180895@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Parvinder Kaur |
| Designation |
Assistant Professor |
| Affiliation |
M.M. COLLEGE OF NURSING |
| Address |
M.M College of Nursing , Mullana, Ambala.
M.M College of Nursing , Mullana, Ambala.
Ambala
HARYANA
133201
India |
| Phone |
9896118890 |
| Fax |
|
| Email |
hparvinder88@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vijaya Bharti |
| Designation |
M.Sc. Nursing |
| Affiliation |
M.M. COLLEGE OF NURSING |
| Address |
M.M cOllege of Nursing , Mullana,Ambala,Haryana.
M.M cOllege of Nursing , Mullana,Ambala,Haryana.
Ambala
HARYANA
136118
India |
| Phone |
7404101035 |
| Fax |
|
| Email |
vijaya180895@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vijaya Bharti
M.M College of Nursing, Mullana, Ambala, Haryana |
|
|
Primary Sponsor
|
| Name |
VIJAYA BHARTI |
| Address |
M.M. College of Nursing,
Mullana, Ambala |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Vijaya bharti |
M.M college of nursing, Mullana , Ambala. |
M.M College of Nursing , M.M,Deemed to be University Mullana, Ambala.
Ambala
HARYANA |
7404101035
vijaya180895@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Communication of Decision of the Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Premenstrual syndrome |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cognitive Behavioural Therapy |
It includes cognitive behavioural therapy techniques for reducing the symptoms of premenstrual syndrome. |
| Comparator Agent |
Not applicable. |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
willing to participate in the study.
available at the time of data collection.
having regular menstrual cycles. |
|
| ExclusionCriteria |
| Details |
Having severe degree of premenstrual syndrome(PMDD).
Using medicines for premenstrual syndrome.
Having any chronic medical or psychiatric illness.
Going to gym. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reducing the symptoms of premenstrual syndrome. |
assessment of the symptoms of premenstrual syndrome will be done by using same tool(premenstrual symptoms screening tool) which was used as pretest at the time of next menstrual cycle on the first day of periods with the help of a google form(self reporting). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reducing the symptoms of premenstrual syndrome among nursing students after administration of cognitive behavioural therapy. |
Reducing the symptoms of premenstrual syndrome at the time of next menstrual cycle upto some extent. |
|
|
Target Sample Size
|
Total Sample Size="86"
Sample Size from India="86"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
12/04/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is to assess the effectiveness of cognitive behavioural therapy on reducing the symptoms of premenstrual syndrome. The objectives of the study included: To assess and compare the symptoms of premenstrual syndrome among nursing students before and after administration of CBT in experimental and comparison group. To find out the association of PMS symptoms among nursing students with their selected sample characteristics in experimental and comparison group. To assess the coping measures used by nursing students for the management of PMS symptoms in experimental and comparison group. |