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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 
Type of Study   Medical Device 
Study Design  Other 
Public Title of Study   To assess the effectiveness of nurse-led intervention on anxiety, stress and pain among women undergoing HysterosalpingographY 
Scientific Title of Study   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   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
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  
 
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  
 
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  
 
Source of Monetary or Material Support  
NINE, PGIMER, CHANDIGARH 
 
Primary Sponsor  
Name  PGIMER Chandigarh 
Address  NATIONAL INSTITUDE OF NURSING EDUCATION, PGIMER, CHANDIGARH, 160012 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
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 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Comittee PGIMER, Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D||Radiation Therapy,  
 
Intervention / Comparator Agent  
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. 
 
Inclusion Criteria  
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
 
 
ExclusionCriteria 
Details  Women having Pelvic pain.
Recent surgery on the tubes or the uterus.
Women having Contrast sensitivity
Immediately post menstruation.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
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. 
 
Secondary Outcome  
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. 
 
Target Sample Size   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" 
Phase of Trial   N/A 
Date of First Enrollment (India)   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 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
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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