| CTRI Number |
CTRI/2019/07/020051 [Registered on: 05/07/2019] Trial Registered Prospectively |
| Last Modified On: |
03/07/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A psychological management nursing intervention for primary infertile couples |
|
Scientific Title of Study
|
An interventional study to evaluate the effectiveness of a “Nursing Management Protocol for Psychosocial Problems†among couples with Primary Infertility on selected outcome variables attending infertility clinic of PGIMER, Chandigarh (2018-20). |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anshuka |
| Designation |
M.Sc. (N) 1st year |
| Affiliation |
National Institute of Nursing Education, PGIMER, Chandigarh |
| Address |
National Institute of Nursing Education, PGIMER, Chandigarh pin code 160012
vill Balh Darbore P O Galore Teh and Distt Hamirpur HP 177026
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7018902674 |
| Fax |
|
| Email |
annysonkhle77@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs V Venkadalakshmi |
| Designation |
Lecturer NINE, PGIMER, Chandigarh |
| Affiliation |
PGIMER, Chandigarh |
| Address |
National Institute of Nursing Education, PGIMER, Chandigarh pin code 160012
National Institute of Nursing Education PGIMER , Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9855552533 |
| Fax |
|
| Email |
Venkadalakshmi_v@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anshuka |
| Designation |
M.Sc. (N) 1st year |
| Affiliation |
National Institute of Nursing Education, PGIMER, Chandigarh |
| Address |
National Institute of Nursing Education, PGIMER, Chandigarh pin code 160012
vill Balh Darbore P O Galore Teh and Distt Hamirpur HP 177026
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7018902674 |
| Fax |
|
| Email |
annysonkhle77@gmail.com |
|
|
Source of Monetary or Material Support
|
| national institute of nursing education, PGIMER, Chandigarh |
|
|
Primary Sponsor
|
| Name |
NINE |
| Address |
National Institute of Nursing Education. |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| PGIMER Chandigarh |
PGIMER, Chandigarh |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Anshuka |
PGIMER, Chandigarh |
Nehru Hospital PGIMER, Chandigarh
Chandigarh
CHANDIGARH |
7018902674
annysonkhle77@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
couple with Primary Infertility |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
control group |
normal routine care |
| Intervention |
Jackobsons progressive Muscle Relaxation technique and counselling on psychosocial aspects. |
JPMR- demonestrated weekly and advice them to practice daily.
counselling-twice per week for 4 weeksand once per week for 2 weeks, follow up -1, 2 , 4 week through telephone and interview. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
36.00 Year(s) |
| Gender |
Both |
| Details |
couples who are diagnosed with primary infertility and willing to participate in the study attending infertility clinic, PGIMER, Chandigarh. |
|
| ExclusionCriteria |
| Details |
couples with major Psychiatric problem |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to evaluate effectiveness of nursing management protocol in primary infertile couples. |
3-4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to assess the Psychosocial problems among couples with primary infertility. |
1 mnth |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/07/2019 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
this article will be published in good peer review journal |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
I am conducting the quasi experimental study on 80 subjects diagnosed with primary infertility, to evaluate the Nursing management protocol for managing Psychosocial symptoms like marital satisfaction, anxiety, depression, anger and decreased libido through jacobson’s Progressive Muscle relaxation and counselling on psychosocial symptoms. the study is conducted into two groups ie. control and intervention group. |