Nursing Intervention Program in the Management of Parental Anxiety and Infant Pain in the Surgical Process of Children to be Circumcised
Primary Purpose
Anxiety, Pain, Postoperative, Child Development
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Intervention group
Control group
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety focused on measuring Anxiety, Child Preschool, Circumcision Male, Pain
Eligibility Criteria
Inclusion Criteria:
- Children aged 0-3 years who are going to undergo circumcision and the relatives/guardians.
Exclusion Criteria:
- Children with micropenis
Sites / Locations
- Policlínica Maresme
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Nursing Intervention
Usual intervention
Arm Description
The intervention group will undergo an education program related to the circumcision process for the child's relatives/guardians.
The control group will receive the usual intervention of the center.
Outcomes
Primary Outcome Measures
Preoperative anxiety level of the parents
The preoperative anxiety level of the parents will be measured using the Hamilton scale. Minimum value 0, Maximum value 56. The higher the score, the higher the anxiety.
Intraoperatively Pain Child
Child pain will be measured using the Face, Legs, Activity, Cry, Consolability scale (FLACC scale). Minimum value 0, Maximum value 10. The higher the score, the higher the pain.
Secondary Outcome Measures
Postoperative telephone follow-up
Postoperative telephone follow-up will be carried out to assess aspects related to the clinical evolution of the surrounded child and the resolution of any doubts that the caregivers may have.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05387291
Brief Title
Nursing Intervention Program in the Management of Parental Anxiety and Infant Pain in the Surgical Process of Children to be Circumcised
Official Title
Effectiveness of the Application of a Nursing Intervention Program in the Management of Parental Anxiety and Infant Pain in the Surgical Process of Children to be Circumcised
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
March 12, 2022 (Actual)
Study Completion Date
May 22, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitat de Girona
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Entering the hospital and waiting for surgery is a very stressful time for people. According to some studies, surgical interventions in children generate in family members concerns related to: anesthesia, fear of being harmed, penile injury, excessive pain, the death of their child, not being able to contain their own anxiety and, therefore, participants may have difficulties in assuming an active role in caring for their child .
For these reasons, the investigators propose the development and implementation of an action program for the reduction of child pain and anxiety in parents in the foreign Muslim population residing in Spain.
Detailed Description
Introduction Entering the hospital and waiting for surgery is a very stressful time for people. According to some studies, surgical interventions in children generate in family members concerns related to: anesthesia, fear of being harmed, penile injury, excessive pain, the death of their child, not being able to contain their own anxiety and, therefore, participants may have difficulties in assuming an active role in caring for their child.
For these reasons, the investigators propose the development and implementation of an action program for the reduction of child pain and anxiety in parents in the foreign Muslim population residing in Spain.
Hypothesis / problem A nursing intervention program in the surgical process of circumcision decreases the degree of anxiety of family members and reduces infant pain.
Methodology A randomized clinical trial will be carried out at the Policlínica Maresme, located in Pineda de Mar, on the relatives/guardians and children aged 0-3 years who are going to undergo circumcision.
The intervention group will undergo an education program related to the circumcision process for the child's relatives/guardians. The control group will receive the usual intervention of the center. It has been estimated that 157 subjects are needed in each group, estimating a loss to follow-up of 10%.
Among other variables, the preoperative anxiety level of the parents will be measured using the Hamilton scale; intraoperatively, child pain will be measured using the FLACC scale and, subsequently, a postoperative telephone follow-up will be carried out during the 2 and 10 days following the intervention, to assess aspects related to the clinical evolution of the surrounded child and the resolution of any doubts that the caregivers may have.
The confidentiality of the study participants will be guaranteed. The research project has been approved by the Comité d'Ètica d'Investigació Clínica amb Medicaments de l'Hospital de Mataró with code CEIm 03/22.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Pain, Postoperative, Child Development
Keywords
Anxiety, Child Preschool, Circumcision Male, Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Subjects will be randomly assigned to one group (intervention) or the other (control).
Masking
Participant
Masking Description
The subjects do not know which group they are in, as some are given the usual intervention (control group) and others the intervention (intervention group).
Allocation
Randomized
Enrollment
314 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nursing Intervention
Arm Type
Experimental
Arm Description
The intervention group will undergo an education program related to the circumcision process for the child's relatives/guardians.
Arm Title
Usual intervention
Arm Type
Other
Arm Description
The control group will receive the usual intervention of the center.
Intervention Type
Behavioral
Intervention Name(s)
Intervention group
Intervention Description
The intervention group will undergo an education program related to the circumcision process for the child's relatives/guardians.
Intervention Type
Behavioral
Intervention Name(s)
Control group
Intervention Description
The control group will receive the usual intervention of the center.
Primary Outcome Measure Information:
Title
Preoperative anxiety level of the parents
Description
The preoperative anxiety level of the parents will be measured using the Hamilton scale. Minimum value 0, Maximum value 56. The higher the score, the higher the anxiety.
Time Frame
Preoperative phase
Title
Intraoperatively Pain Child
Description
Child pain will be measured using the Face, Legs, Activity, Cry, Consolability scale (FLACC scale). Minimum value 0, Maximum value 10. The higher the score, the higher the pain.
Time Frame
Intraoperatively Phase
Secondary Outcome Measure Information:
Title
Postoperative telephone follow-up
Description
Postoperative telephone follow-up will be carried out to assess aspects related to the clinical evolution of the surrounded child and the resolution of any doubts that the caregivers may have.
Time Frame
Days 2 and 10 after the intervention.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Months
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Children aged 0-3 years who are going to undergo circumcision and the relatives/guardians.
Exclusion Criteria:
Children with micropenis
Facility Information:
Facility Name
Policlínica Maresme
City
Pineda De Mar
State/Province
Barcelona
ZIP/Postal Code
08397
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The data will only be used by the study investigators.
Learn more about this trial
Nursing Intervention Program in the Management of Parental Anxiety and Infant Pain in the Surgical Process of Children to be Circumcised
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