1. Home
  2. Approved trials
  3. » فارسی

The Effect of a Supportive- Educational Program on Anxiety and Satisfaction of Mothers of Children undergoing the Lumbar puncture: compared to non-receipt of such intervention as control group

Protocol summary

Summary
Study objective: The aim of this study was to determine the effect of supportive - educational program on the anxiety and satisfaction of mothers of children undergoing Lumbar puncture. Design: This study was a semi-experimental clinical trial, with two groups (intervention and control), pre-posttest design, and single not-blind. Sample size: This study was conducted on 60 children’s mothers (30 mothers per each group) hospitalized in pediatric emergency department of Quaem, Dr Sheikh, and Imam Reza hospitals of Mashhad. The main outcome variables in this study included: Anxiety and satisfaction. Inclusion criteria: Mother's age between 18 years to 55 years old; not experienced major stressors (such as divorce) within 6 month before; lack of sedatives and anti-anxiety drugs within 2 days before the test, and children's age between 1 month to 14 years old. Exclusion criteria: Children required emergency lumbar puncture test and, lack of cooperation mother to participate in the post test. Sampling was conducted via convenience sampling method, at the beginning of sampling; in order to avoid from information distribution between two groups, the first group was selected by a simple draw, and the intervention group was selected as first group. The mothers in the experimental group received an educational-supportive program (that included: Informational and emotional supports for 70 minutes), and an information booklet. The control group did not receive any intervention. Data were collected by demographic and spielburger questionnaires. The anxiety level was measured before and after the intervention (immediately before the LP) in two groups. Also, the satisfaction of mothers from preparation before the lumbar puncture test in their children were measured by the researcher-made questionnaire at 3 hours after Lumbar puncture test in two groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015110224845N1
Registration date: 2016-02-13, 1394/11/24
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-02-13, 1394/11/24
Registrant information
Name
Akhtar Nejat Mohammad
Name of organization / entity
Mashhad Faculty of Nursing and Midwifery, Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3523 2319
Email address
nejatma1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
University of Medical Sciences Mashhad, Vice chancellor for research
Expected recruitment start date
2015-07-18, 1394/04/27
Expected recruitment end date
2015-09-29, 1394/07/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of a Supportive- Educational Program on Anxiety and Satisfaction of Mothers of Children undergoing the Lumbar puncture: compared to non-receipt of such intervention as control group
Public title
Effect of a Supportive- Educational Program on Anxiety and Satisfaction of Mothers of Children undergoing the Lumbar puncture (LP)
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Mother's age between 18 years to 55 years old; not experienced major stressors (such as divorce) within 6 month before; not receiving sedatives and anti-anxiety drugs within 2 days before the test, and children's age between 1 month to 14 years old. Exclusion criteria: Children required emergency lumbar puncture test, and lack of cooperation mother to participate in the post test.
Age
From 18 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Not randomized
Randomization description
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 of Mashhad University of Medical Sciences
Street address
University of Medical Sciences Mashhad, Vice chancellor for research, Ghoraishy Building, University St
City
Mashhad
Postal code
Approval date
2015-06-22, 1394/04/01
Ethics committee reference number
IR.MUMS.REC.1394.212

Health conditions studied

1

Description of health condition studied
Anxiety
ICD-10 code
F41
ICD-10 code description
Disorders in which manifestation of anxiety is the major symptom

Primary outcomes

1

Description
Mother anxiety
Timepoint
Spielberger state trait anxiety inventory (STAI)
Method of measurement
Before intervention and immediately before lumbar puncture test for child in two groups (experimental and control)

2

Description
Mother satisfaction
Timepoint
Three hours after the intervention in two groups (experimental and control)
Method of measurement
Researcher-made questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The experimental group in this study was received a supportive program by the researcher (70 minutes). This program was conducted in two stages. Stage1: The first part was about the informational support (30 minute), that included, talking and giving adequate information about lumbar puncture test, (method test, benefits, side effects lack of testing, and necessary cares after the test) and, answering the mother's questions about lumbar puncture test. Then, the mother was given ten minute rest break. After rest break, stage 2: The second part program was about emotional support (30 minute), that included: At first, showing a supportive movie the mother for (15 minute) that content of movies: interview whit parents which the lumbar puncture test were performed for their children. After showing film, encouraging the mother to talk about concerns and fears; expressing feelings about lumbar puncture test, and ensuring her about the safety test (15 minute). In the end supportive program, the mothers given an information booklet about lumbar puncture test.
Category
Behavior

2

Description
Control group: in this study, no intervention was administered to the control group
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Quaem Hospital
Full name of responsible person
Mina Delghandi
Street address
Pediatric Emergency Department, Quaem Hospital, Ahmad Abad St, Dr Shariati Square, Mashhad
City
Mashhad

2

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Manizheh Vazifedost Khalaj
Street address
Pediatric Department, Imam Reza Hospital, Ebne Sina St, Imam Reza Square, Mashhad
City
Mashhad

3

Recruitment center
Name of recruitment center
Dr Shaikh Hospital
Full name of responsible person
Nadia Tavakolian
Street address
Pediatric Emergency Department, Dr Shaikh Hospital, Taheri Street, Tohid Square, Mashhad
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of Medical Sciences Mashhad, Vice chancellor for research
Full name of responsible person
Mohsen Tafaghodi
Street address
University of Medical Sciences Mashhad, Vice chancellor for research, Ghoraishy Building, University St
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Medical Sciences Mashhad, Vice chancellor for research
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
Mashhad Faculty of Nursing and Midwifery
Full name of responsible person
Akhtar Nejat Mohammad
Position
Master of Science student in pediatric Nursing
Other areas of specialty/work
Street address
Mashhad Faculty of Nursing and Midwifery, Ebne Sina St, Doktora Crossroads
City
Mashhad
Postal code
Phone
+98 515232319
Fax
Email
NejatMA1@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad Faculty of Nursing and Midwifery
Full name of responsible person
Mousa Mahdizadeh
Position
PhD Candidate in Nursing
Other areas of specialty/work
Street address
Mashhad Faculty of Nursing and Midwifery, Ebne Sina St, Doktora Crossroads
City
Mashhad
Postal code
Phone
+98 51 3859 1511
Fax
+98 518597313
Email
MahdizadehM@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad Faculty of Nursing and Midwifery
Full name of responsible person
Akhtar Nejat Mohammad
Position
Master of Science student in pediatric Nursing
Other areas of specialty/work
Street address
Mashhad Faculty of Nursing and Midwifery, Ebn-e Sina St, Doktora Crossroads
City
Mashhad
Postal code
Phone
+98 51 3523 2319
Fax
Email
NejatMA1@mums.ac.ir
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...