| CTRI Number |
CTRI/2022/07/043902 [Registered on: 11/07/2022] Trial Registered Prospectively |
| Last Modified On: |
20/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
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Medical Device |
| Study Design |
Other |
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Public Title of Study
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To assess the effectiveness of nurse-led intervention on anxiety, stress and pain among women undergoing HysterosalpingographY |
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Scientific Title of Study
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A Randomized Control Trial to assess the effectiveness of nurse-led intervention on anxiety, stress and pain among women undergoing Hysterosalpingography in NEW OPD and Radiological Department, Nehru Hospital, PGIMER, Chandigarh (2021-23). |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
Kirti |
| Designation |
M.Sc. nursing Student |
| Affiliation |
NINE, PGIMER |
| Address |
National institute of nursing, room no. 211, PGIMER, Chandigarh UT
Chandigarh CHANDIGARH 160012 India |
| Phone |
7018173619 |
| Fax |
|
| Email |
kirtisharma2695@gmail.com |
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Details of Contact Person Scientific Query
|
| Name |
VVenkadalakshmi |
| Designation |
Lecturer |
| Affiliation |
NINE, PGIMER |
| Address |
NATIONAL INSTITUDE OF NURSING EDUCATION, PGIMER, CHANDIGARH, 160012
India
Chandigarh CHANDIGARH 160012 India |
| Phone |
9855552533 |
| Fax |
|
| Email |
venkadalakshmi_v@rediffmail.com |
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Details of Contact Person Public Query
|
| Name |
VVenkadalakshmI |
| Designation |
Lecturer |
| Affiliation |
NINE, PGIMER |
| Address |
NATIONAL INSTITUDE OF NURSING EDUCATION, PGIMER, CHANDIGARH, 160012
Chandigarh CHANDIGARH 160012 India |
| Phone |
9855552533 |
| Fax |
|
| Email |
venkadalakshmi_v@rediffmail.com |
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Source of Monetary or Material Support
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Primary Sponsor
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| Name |
PGIMER Chandigarh |
| Address |
NATIONAL INSTITUDE OF NURSING EDUCATION, PGIMER, CHANDIGARH, 160012 |
| Type of Sponsor |
Research institution and hospital |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| KIRTI |
PGIMER, CHANDIGARH |
ROOM NO -2046 AT NEW OPD AND GROUND FLOOR RADIOLOGICAL DEPARTMENT AT NEHRU HOSPITAL, PGIMER, CHANDIGARH, 160012 Chandigarh CHANDIGARH |
7018173619
kirtisharma2695@gmail.com |
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Details of Ethics Committee
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| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comittee PGIMER, Chandigarh |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D||Radiation Therapy, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Comparator Agent |
Control group will be given routine care. |
Control group will be given routine care as prescribed by doctor and will be assessed for anxiety, stress and pain level of the women. |
| Intervention |
Nurse-led intervention on anxiety, stress and pain among women undergoing Hysterosalpingography. |
Providing counselling and video information to the patients to reduce the anxiety of women and indirectly decrease the pain level during procedure. Guided imaginary during procedure help to reduce the pain of the women during procedure. Anxiety, stress and pain level will be assessed after 10 min. of procedure. |
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Inclusion Criteria
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| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Women who are willing to participate.
Women with infertility.
Women with suspected uterine anomalies
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| ExclusionCriteria |
| Details |
Women having Pelvic pain.
Recent surgery on the tubes or the uterus.
Women having Contrast sensitivity
Immediately post menstruation.
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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An Open list of random numbers |
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Blinding/Masking
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Not Applicable |
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Primary Outcome
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| Outcome |
TimePoints |
| To assess the effectiveness of nurse-led intervention on anxiety, stress and pain among women undergoing Hysterosalpingography in NEW OPD and Radiological Department, Nehru Hospital, PGIMER, Chandigarh |
Primary outcome will be assessed i.e. at post procedure 10 min. |
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Secondary Outcome
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| Outcome |
TimePoints |
| To develop and implement protocol to reduce the anxiety, stress and pain among women undergoing Hysterosalpingography. |
Secondary outcome will be assessed i.e. at post procedure 10 min. |
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Target Sample Size
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Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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N/A |
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Date of First Enrollment (India)
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16/07/2022 |
| 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 |
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Estimated Duration of Trial
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Years="1" Months="0" Days="0" |
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Recruitment Status of Trial (Global)
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Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
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INTRODUCTION AND NEED:- Infertility is a disorder of reproductive system defined by the failure to obtain a clinical pregnancy following a period of 12 months or more regular unprotected sexual contact. Infertility is classified as either primary or secondary. Primary infertility is the absence of pregnancy for a couple who desires a child after 12 months or more of regular unprotected sexual intercourse, during which they have not taken any contraceptives. On the other hand secondary infertility is defined as the lack of a live birth for women who wish a child and have been in a union for at least five years since their last live birth, during which they did not use any contraceptive. For the diagnosis of the infertility, female genital tract anatomy is assessed by the radiographical imaging. Anatomy of female genital tract is essential component for the investigation of infertility. To evaluate the patency of the fallopian tubes, morphology of the uterus and cervix radiographical test i.e. Hysterosalphingography is used. Hysterosalpingo-contrast sonography is a radiation free valuable method for the assessment of fallopian tube patency, uterine wall and cavity, overies and peritoneum. It was also observed that the level of anxiety in women awaiting HSG significantly higher compared to women awaiting mammography or abdominal ultrasonography. Women undergoing HSG experience stress before and during this examination. Infertility itself also cause prolonged stress and distress for the couple who involved.. So providing counselling and video information to the patients is an important step to reduce the anxiety of women and indirectly decrease the pain level. Guided imaginary during procedure help to reduce the pain of the patient during procedure. So the nurse led intervention reduce the anxiety ,stress and pain of the women to some extent. OBJECTIVES:- To assess the pre-interventional state of anxiety and stress for women undergoing Hysterosalpingography in Radiological Department, Nehru Hospital,PGIMER ,Chandigarh among experimental and research group. To develop and implement nurse-led interventions for women undergoing Hysterosalpingography in Radiological Department, Nehru Hospital,PGIMER, Chandigarh in experimental group. To evaluate the effectiveness of nurse-led intervention on anxiety, stress and pain among women undergoing Hysterosalpingography in Radiological Department, Nehru Hospital,PGIMER ,Chandigarh among experimental and research group. Nurse led Intervention:- In this study, nurse led intervention refer to care given in systemic manner to women undergoing Hysterosalpingography. To relive women anxiety and stress, counseling and informational video will given before procedure. And to relive women pain during procedure deep breathing ,progressive muscle relaxation and guided imagery will be given by the researcher.
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