NATIONAL INSTITUTE OF NURSING EDUCATION

POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH

CHANDIGARH – 160012(INDIA)
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).

GUIDE:
Mrs. Venkadalakshmi
Lecturer
NINE, PGIMER, Chandigarh

Co- Guide Co-Guide

Dr. Manju Dhandapani Dr. Shalini Gainder

Lecturer Additional Professor

NINE , PGIMER Department of Obstetrics and Gynaecology
Chandigarh PGIMER, Chandigarh

PRINCIPAL

Dr. Karobi Das

Officiating Principal
NINE,PGIMER
Chandigarh
 ANNEXURE-1
Participant Information Sheet (PIS) (women undergoing HSG)

CODE

PRINCIPAL INVESTIGATOR: KIRTI

Name of Participant:

Title: " 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).”

1. You are invited to take part in this research study.

The information in this document is meant to help you decide whether or not to take part.
Please feel free to ask if you have any queries or concerns. Your are being recruited to
participate in this study being conducted in selected NEW OPD and Radiological
Department, Nehru Hospital, PGIMER,Chandigarh, as you satisfy the eligibility criteria.

You will be one of the participants we plan to recruit in this study. You will be recruited
either to the Experimental or Control group.

2. What is the purpose of the research study?

The aim of present study is to assess the effectiveness of a Nurse Led Intervention on
anxiety, stress and pain among women undergoing Hysterosalpingography. I want to give
pre-procedural counseling, information video to the participant to reduce post procedure
anxiety and pain score The Duration of the intervention will be 3 months. In the study
interview, demonstration, return demonstration, intervention and assessment will be
done. Intervention done by nurse would be beneficial to the patient.
I will obtain permission from the Ethics Committee, PGIMER, Chandigarh.

3. The study design?

The study design will be Randomized Control Trial. All the patients in the study will be
divided into two groups. You will be assigned to either of two groups as determined
purely by chance, which, in scientific language, is called as "randomization.

4. What is your expected duration of the participation?

Your participation in this study will last till HSG completion.

5. What procedures will be followed during this study?

 Teaching include the :-
 Informational video
 Counseling
 Deep breathing
 Progressive muscle relaxation
 Guided imagery

6. What are the risks and discomforts to you?

There is no risk associated with teaching because couple will develop their innate skills to
handle the current situation.

7. What benefits are expected from this research?

It will have a positive effect on reducing the Psychological Symptoms like anxiety, stress
and pain.

8. What are the alternatives available to you?

If you don't wish to participate you have the alternative to refuse to be part of the study.

9. Are the data/records of the participant kept confidential?

Yes, the data records of the participant will be kept confidential.

10. What will be the treatment schedules?

Treatment schedule will be demonstration of deep breathing along with the Psychosocial
counseling, Informational video and Guided imagery.

11. What compensation and/or treatments are available to the Participant in the event
of a trial-related injury?
Women will be treated for any complication related to intervention though there is less
chance.

12. Whom to contact for trial related queries and what are the rights of Participants in
the event of any injury?
Participants can contact the principal investigator and guide or co-guides involved in the
study.

13. Are the participants paid to take part in this study?

No

14. What are your responsibilities during participation in the study?

 I will take care of the maintenance of confidentiality and anonymity of the participants
and to carry out an intervention without any harm to patient.

15. Participation is voluntary, that the Participant can withdraw from the study at any time
and that refusal to participate will not involve any penalty or loss of benefits to which the
Participant is otherwise entitled.

16. Statement that the Participant or Participant's representative will be notified in a timely
manner if significant new findings develop during the course of the research which may
affect the Participant's willingness to continue participation will be provided.

17. No additional costs will be incurred from the study.

18. Your decision to not to participate in this research will not affect your relationship with
the investigator or the institution. You will not lose any benefits for which you are
entitled.

19. If you don't wish to participate, you have the alternative to refuse to be part of study

20. Approximate number of Participants enrolled in the study will be around 60.

Contact persons:

For further information/ questions, you can contact us at the following address:-

Principal investigator:

Kirti

M. Sc. Nursing (Obstetrics and Gynaecology Nursing)

National Institute of Nursing Education (NINE)

Postgraduate Institute of Medical Education and Research

Chandigarh, India. 160012

Phone no.7018173619; email: kirtisharma2695@gmail.com

Co-investigators:

Mrs V. Venkadalakshmil

Lecturer, NINE, PGIMER, Chandigarh

Phone no. 9855552533

Dr. Manju Dhandapani

Lecturer, NINE,PGIMER, Chandigarh

Dr. Shalini

Associate Professor, Obstetrics and Gynecology department, PGIMER,Chandigarh

 ANNEXURE-2
Documentation of the Informed Consent
Title: " 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).”

Participant name:-

Investigator:-Kirti

Co- Investigator:- Mrs Venkadalakshmil

Name of institution:- PGIMER, Chandigarh

I ____________________ have read the information in this form (or it has been read to me). I
was free to ask any questions and they have been answered. I am over 18 years of age and,
exercising my free power of choice, hereby give my consent for A Randomized Controlled Trial
to assess the effectiveness of “Nurse-led intervention” on anxiety, stress and pain among women
undergoing Hysterosalpingography in Radiological Department, Nehru Hospital,PGIMER
Chandigarh (2021-23).

1) I have read and understood this consent form and the information provided to me.

2) I have had the consent document explained to me.

3) I have been explained about the nature of the study.

4) My rights and responsibilities have been explained to me by the investigator.

5) I have been advised about the risks associated with participation in the study.

6) I agree to cooperate with the investigator and I will inform him/ her immediately if I suffers
unusual symptoms.

7) I am aware of the fact that I can opt out of the study at any time without having to give any
reason and this will not affect my future treatment in the hospital.

8) I am also aware that the investigators may terminate my participation in the study at any time,
for any reason, without my consent.

9) I hereby give permission to the investigators to release the information obtained from me as
result of participation in this study to the regulatory authorities, Government agencies, and ethics
committee. I understand that they may inspect my original records.
10) My identity will be kept confidential if his/ her data is publicly presented.

11) I have had my questions answered to my satisfaction.

12) I have decided to be in the research study am aware that if I have any questions during this
study, I should contact at address listed above. By signing this consent form, I attest that the
information given in this document. I will be given a copy of this document.

Participant’s initials: _______________

Investigator Certificate

I certify that all the elements including the nature, purpose and possible risks of the above study
as described in this consent document have been fully explained to the participant. In my
judgment, the participant possesses the legal capacity to give informed consent to participate in
this research and is voluntarily and knowingly giving informed consent to participate.

Signature of the Investigator: ___________ Date : ___________

Name of the Investigator: ___________________

 ANNEXURE-3
SOCIO DEMOGRAPHIC VARIABLE

INSTRUCTION: Respected respondent go through the following statement:-

 Read the entire question carefully.

 Carefully and complete the items by placing tick marks ( ) to approximate answer.

1. Name

2. Age in year

3. Gender
a) Male
b) Female
c) Transgender
4. Source of information
a) News paper
b) Mass media
c) Magazine
d) Other sources
5. Occupation
a) Business
b) Unskilled
c) Skilled
d) Agriculture
e) Professional
f) Not working
6. Education
a) Illiterate/ literate
b) Primary
c) Middle
d) Matric
e) Inter/ Diploma
f) Graduate
7. Religion
a) Hinduism
b) Sikhism
c) Christian
d) Other
e) Not known
8. Address:-

9. Contact no.:-

10. Type of family:-

a) Nuclear family
b) Single parent family
c) Extended family
d) Childless family

11. Income of family per month:-

a) > 10,000
b) 10,000-25,000
c) 25,000-50,000
d) 50,000<

12. No. of family members:-

a) >5
b) 5-10
c) 10-15
d) 15<

13. Dietary habits:-

a) Vegetarian diet
b) Non-vegetarian diet
c) Liquid diet
d) Bland diet

14. Personal habits:-

a) Smoking
b) Eating balanced diet
c) Dancing
d) Any other, specify
 ANNEXURE-4
CLINICAL PROFILE SHEET

Sr. no. Maternal data

1. Name

2 Age

3 First day of last menstrual period

4 Duration of menstrual cycle

5 Age at the time of marriage

6 Duration of marriage

7 Duration of infertility

8 Type of infertility

9 Previous treatment

10 Duration of treatment

11 Partner checked for sperm count

12 Any type of pelvic surgery

13 No. of reproductive therapy

14 Allergy to any of things

1. X-Ray Contrast -
2. Iodine -
3. Food -
4. Medication -

15 Treatment taken for co-morbidity:-

 ANNEXURE-5
Zung Self-rating Anxiety Scale

Name: Date: .

Listed below are 20 statements. Please read each one carefully and decide how much the
statement describes how you have been feeling during the past week. Circle the appropriate
number for each statement.

None or a Some Good Most or

little of of the part of all of
the time time the time the time
1. I feel more nervous and anxious than usual.

2. I feel afraid for no reson at all.

3. I get upset easily or feel panicky.
4. I feel like I’m falling apart and going to pieces.

5. I feel that everything is all right and nothing

bad will happen.
6. My arms and legs shake and tremble.
7. I am bothered by headaches, neck and back
pains.
8. I feel weak and get tired easily.
9. I feel calm and can sit still easily.
10. I can feel my heart beating fast.
11. I am bothered by dizzy spells.
12. I have fainting spells or feel faint.
13. I can breathe in and out easily.
14. I get feeling of numbness and tingling in my
fingers and toes.
15. I am bothered by stomachaches or indigestion.
16. I have to empty my bladder often.
17. My hands are usually dry and warm.
18. My face gets hot and blushes.
19. I fall asleep easily and get a good night’s rest.
20. I have nightmares.

Score Total=
 ANNEXURE-6

Perceived Stress Scale

The question in this scale ask you about your feelings and thoughts duing THE LAST MONTH.
In each case, you will be asked to indicate by circling how often you felt or thought a certain
way. Although some of the questions are similar, there are difference between them and you
should treat each one as a separate question. The best approach is to answer fairly quickly.

Name: Date: .

Age: Gender (Circle): M / F Other .

0=Never 1=Almost Never 2=Sometimes 3= Fairly Often 4= Very Often.

1. In the last month, how often have you been upset because of 0 1 2 3 4
something that happened unexpectedly?
2. In the last month, how often have you felt that you were unable 0 1 2 3 4
to control the important things in your life?
3. In the last month, how often have you felt nervous and 0 1 2 3 4
stressed?
4. In the last month, how often have you felt confident about your 0 1 2 3 4
ability to handle your personal problems?
5. In the last month, how often have you felt that things were 0 1 2 3 4
going your way?
6. In the last month, how often have you found that you could not 0 1 2 3 4
cope with all the things that you had to do?
7. In the last month, how often have you been angered because of 0 1 2 3 4
things that were outside of your control?
8. In the last month, how often have you felt difficulties were 0 1 2 3 4
piling up so high that you could not overcome them?
9. In the last month, how often have you been able to control 0 1 2 3 4
irritations in your life?
10. In the last month, how often have you felt that you were on top 0 1 2 3 4
of things?
 ANNEXURE-7

Visual Analogue Scale (VAS)

Choose a Number from 0 to 10 That best Describes Your Pain

No Distressing Unbearable
Pain Pain Pain

0 1 2 3 4 5 6 7 8 9 10

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