Determining the Effect of Mother Recorded Voice on the Severity of Pain and Anxiety in Pediatric Patients Admitted to the Hospital of Ali ibn Abitaleb Zahedan in 2019
Design
Clinical trials with control group; randomized, community-based and practical, with parallel groups without blinding.
Settings and conduct
Children undergoing abdominal surgery in Ali ibn Abi Talib Hospital are randomly divided into two groups, and the voice of the mother is recorded on the day before the operation and is distributed to the child in two stages with headphones pleyed. preoperative anxiety And the pain is after surgery measured.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Surgery in the lower abdomen; The child's desire to hear the voice of the mother;
Non-emergency surgery;
Anesthesia (general anesthetic) and surgery protocols are the same;
Mother's presence.
Non-inclusion criteria: The occurrence of specific problems during surgery (bleeding beyond the limit, re-intubation of the trachea);
Having long-lasting illness in the last 3 months;
Having a history of surgery within last year;
Presence of hyperactivity disorder or other mental disorders (according to the patient's history);
Hearing disorder.
Intervention groups
Intervention group: The mother's voice is played in two stages. The first stage is to reduce preoperative anxiety and the second stage is used to reduce postoperative pain. The sound content includes poetry or speech, related to the request of the child.
In the control group, the headphones are connected to the silent device on the child's ear.
Main outcome variables
Anxiety; the amount of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181214041960N1
Registration date:2019-02-06, 1397/11/17
Registration timing:prospective
Last update:2019-02-06, 1397/11/17
Update count:0
Registration date
2019-02-06, 1397/11/17
Registrant information
Name
Fateme Avizhgan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4487 3295
Email address
avizhgan_f@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2019-09-21, 1398/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of mother's recorded voice on the severity of pain and anxiety in pediatric undergoing surgery
Public title
The effect of mother's voice on the pain and anxiety of children
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Surgery in the lower abdomen
The child's desire to hear the voice of the mother
Non-emergency surgery
Anesthesia (general anesthetic) and surgery protocols are the same
Mother's presence
Exclusion criteria:
The occurrence of specific problems during surgery (bleeding beyond the limit, re-intubation of the trachea)
Having long-lasting illness in the last 3 months
Having a history of surgery within last year
Presence of hyperactivity disorder or other mental disorders (according to the patient's history)
Hearing disorder
Age
From 3 years old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Envelopes containing cards with numbers one and two are given to the participants, if the number one is chosen, they will be assigned to the intervention group. Otherwise they will be assigned to the control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee Zahedan University of Medical Sciences and Health Services
Street address
Zahedan University of Medical Sciences, Janat Blvd
On entering the operating room and 15 minutes after the intervention
Method of measurement
Modified- Yale preoperative anxiety scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Mother's voice is used in two stages. The first stage was to reduce the anxiety before surgery and the second time to reduce postoperative pain. According to the request of the child or his mother, the content of the sound includes poetry or regular speech to reduce the child's anxiety. In the second step, the mother is given a written text that she will read it to reduce the pain after surgery.
Category
Rehabilitation
2
Description
Control group: The headphones connected to the silent device are placed on the child's ear.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Abne Abitaleb Hospital affiliated to Zahedan University of Medical Sciences and Health Services
Full name of responsible person
Fateme Avizhgan
Street address
Zahedan University of Medical Sciences, Janat Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5796
Email
avizhgan.sara73@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Normohammad Bakhshany
Street address
Zahedan University of Medical Sciences, Janat Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5796
Fax
Email
avizhgan.sara73@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Fateme Avizhgan
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery Faculty، Behdasht Blvd,
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2481
Email
avizhgan.sara73@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Fateme Avizhgan
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Zahedan Nursing and Midwifery Faculty, Behbasht blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2481
Email
avizhgan.sara73@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Fateme Avizhgan
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery,Behdaht blvd,
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2481
Email
avizhgan.sara73@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available