1. Home
  2. Approved trials
  3. » فارسی

The effect of "nurse companionship" program on health outcomes of mothers undergoing cesarean section

Protocol summary

Summary
this study will be carried out with the aim of identifying the effect of “Nurse Companionship” plan on health outcomes in mothers who are candidate for cesarean section. To achieve specific aims, the anxiety level 1 hour before and 1 hour after the surgery, level of satisfaction 1 hour after surgery, pain severity and vital signs 1 hour before surgery, when the mother is placed on surgery bed and 1 hour after surgery will be measured in both groups.The present study is a clinical trial which will be carried out in Tabriz Alzahra Teaching Hospital after getting permission from research vice chancellor and ethics committee. To do the study the mothers, who are candidate for cesarean section, will be selected randomly considering inclusion criteria. Afterwards, they will be appointed to either intervention or control group. Control group will receive the routine care. The intervention group will get nurse support and companionship before the surgery starts until the end of the surgery. The nurse will start process of supporting by introducing herself to the mothers in control group and elaborating on the study aims, taking mothers’ hand in her hand, having eye contact, educating them what they need, answering their question and diverting their attention. It will be also explained to the mothers that the nurse will be with them during the surgery and will answer all their questions if possible. The anxiety level will be measured using Spielberger anxiety questionnaire, the pain level using visual analogue scale (VAS), level of satisfaction using Tabbi patient’s satisfaction questionnaire and vital signs values using digital blood pressure monitor ALPK. The collected data will be analyzed.

General information

Acronym
--
IRCT registration information
IRCT registration number: IRCT2016081727561N3
Registration date: 2016-12-09, 1395/09/19
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-12-09, 1395/09/19
Registrant information
Name
Mojgan Lotfi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3479 6770
Email address
mlotfi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences.
Expected recruitment start date
2016-10-22, 1395/08/01
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of "nurse companionship" program on health outcomes of mothers undergoing cesarean section
Public title
Clinical trial program "nurse companionship" on health outcomes of mothers undergoing cesarean section
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: Candidate for cesarean, Mothers with Non-emergency cases؛ No nulliparous mothers؛ Mothers consciousness enough to cooperate؛ Effective communication between mothers and nurses؛ No maternal history of allergy to spinal anesthesia؛ No high risk situation for the baby؛ Single and term pregnancy. Exclusion Criteria: Unsuccessful spinal anesthesia, Receive general anesthesia؛ Need another surgery (Hysterectomy)؛ History of taking Anti-anxiety drugs؛ Suffering from any mental problems؛ History of Kidney disease, Cardiovascular disease, Hearing problem and etc.؛ History of Gestational diabetes, Preeclampsia, Polyhydramnios and etc؛ History of HIV And Hepatitis؛ Any thing out of the surgerys routines occur in surgery؛ Want to exit the study.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 128
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Blocking method

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
International Relations Office, No 2 Central Building, Tabriz University of Medical Sciences, University Street
City
Tabriz
Postal code
Approval date
2016-09-26, 1395/07/05
Ethics committee reference number
IR.TBZMED.REC.1395.682

Health conditions studied

1

Description of health condition studied
Health outcomes of mothers candidate for cesarean section
ICD-10 code
Z71.9
ICD-10 code description
Counselling, unspecified

Primary outcomes

1

Description
Anxiety
Timepoint
1 hour before and 1 hour after the surgery
Method of measurement
Spielberger anxiety questionnaire

2

Description
Pain
Timepoint
1 Hour before surgery, when the mother is placed on surgery bed and 1 hour after surgery
Method of measurement
Visual analogue scale (VAS)

3

Description
Vital sign
Timepoint
1 Hour before surgery, when the mother is placed on surgery bed and 1 hour after surgery
Method of measurement
Digital blood pressure monitor ALPK

Secondary outcomes

1

Description
Satisfaction
Timepoint
1 Hour after surgery
Method of measurement
Tabbi patient’s satisfaction questionnaire

Intervention groups

1

Description
Control group: This routine care includes: accepted the mother in the unit, preparing file, check out routine tests of cesarean section, wear of surgery gun, notice and transfer to the operating room, transfer the mother to the waiting room and then operating table, induction of spinal anesthesia, surgery begins, transfer the mother to recovery after surgery, the recovery and after the return of legs anesthesia transfer the mother to the unit. It should be noted that all the above tasks done by staff the center and without the presence of a researcher.
Category
N/A

2

Description
Intervention group: Mother candidate for cesarean in addition to receive routine care, will get nurse support and companionship 1 hour before the surgery starts until the 1 hour after the surgery. The nurse will start process of supporting by introducing herself to the mothers and elaborating on the study aims, taking mothers’ hand in her hand, having eye contact, educating them what they need, answering their question and diverting their attention. It will be also explained to the mothers that the nurse will be with them during the surgery and will answer all their questions if possible.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra Teaching Hospital
Full name of responsible person
Elmira Aghaii
Street address
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Reza Rashidian
Street address
Daneshgah Street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Elnaz Asghari
Position
Candidate for Ph.D Nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Shariati Street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3479 6969
Fax
Email
asghari.elnaz@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mojgan Lotfi
Position
Assistant Professor
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Shariati Street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3479 6969
Fax
Email
Mojgan.lotfi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Elmira Aghaii
Position
Master of Nursing Student
Other areas of specialty/work
Street address
Alzahra Hospital, Bagshomal Street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3553 9161
Fax
Email
e.aghaii1984@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...