| CTRI Number |
CTRI/2023/08/055971 [Registered on: 01/08/2023] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Nurse led interventions] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
An study to assess the effectiveness of nurse led intervention on the selected variable among the women with infertility undergoing intra uterine insemination in New OPD, PGIMER Chandigarh. |
|
Scientific Title of Study
|
An experimental study to assess the effectiveness of nurse led intervention on the selected variable among the women with infertility undergoing intra uterine insemination in New OPD, PGIMER Chandigarh. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Munisha Kumari Thakur |
| Designation |
Msc. nursing student |
| Affiliation |
NINE, PGIMER, Chandigarh |
| Address |
Room no. 208, NINE, PGIMER, Chandigarh
160012
India
Room no.320, 3rd floor, NINE,PGIMER, Chandigarh
160012
India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9882675748 |
| Fax |
|
| Email |
thakurmunisha256@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Venkadalakshmi |
| Designation |
Associate professor |
| Affiliation |
NINE, PGIMER, Chandigarh |
| Address |
Room no. 320, NINE, PGIMER, Chandigarh
160012
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9855552533 |
| Fax |
|
| Email |
venkadalakshmi_v@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr V Venkadalakshmi |
| Designation |
Associate professor |
| Affiliation |
NINE, PGIMER, Chandigarh |
| Address |
Room no. 320, NINE, PGIMER, Chandigarh
160012
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9855552533 |
| Fax |
|
| Email |
venkadalakshmi_v@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Infertility clinic, New OPD, PGIMER, Chandigarh |
|
|
Primary Sponsor
|
| Name |
Infertility clinic, Room no. 2046, New OPD, PGIMER, Chandigarh |
| Address |
Sector 12, PGIMER, Chandigarh
160012
India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| National Institute of Nursing Education |
NINE, 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 |
| Dr Aashima Arora |
New OPD, PGIMER Chandigarh |
Room no.2046, infertility clinic, New OPD, PGIMER, Chandigarh India
160012
Chandigarh
CHANDIGARH |
9915501844
aashicool84@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, PGIMER, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N979||Female infertility, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nurse led intervention for the women with infertility |
nurse led intervention include therapeutic communication related to IUI procedure, explanation and demonstration of deep breathing exercises and counselling related to hope therapy to the women with infertility undergoing intrauterine insemination |
| Comparator Agent |
Routine care |
Instructions regarding post intrauterine insemination care |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Women diagnosed with infertility willing to participate in the study |
|
| ExclusionCriteria |
| Details |
women with pre existing mental illness |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Stress, anxiety, level of pain |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Rate of conception |
1month after IUI |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/08/2023 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
My study to assess the effectiveness of nurse led intervention on selected variable among the women with infertility undergoing intrauterine insemination. I will check the stress and anxiety and pain during procedure among the women with infertility undergoing intrauterine insemination. i will also provide interventions such as therapeutic communication, deep breathing exercises and hope therapy. At follow up i will check the effectiveness of my intervention such as reduction in stress and anxiety, rate of conception among women with infertility. |