Nursing Intervention Program in the Management of Parental Anxiety and Infant Pain in the Surgical Process of Children to be Circumcised

Not Applicable

Completed

• Conditions: Pain, Postoperative; Anxiety; Child Development
• Interventions: Behavioral: Intervention group; Behavioral: Control group

• Registration Number: NCT05387291
• Lead Sponsor: Universitat de Girona

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

1. 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.

2. Hypothesis / problem A nursing intervention program in the surgical process of circumcision decreases the degree of anxiety of family members and reduces infant pain.

3. 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.

Study Timeline

• Study Start: 2022-02-01
• Primary Completion: 2022-03-12
• Study First Submitted: 2022-05-12
• Study First Submitted QC: 2022-05-18
• Study Completion: 2022-05-22
• Study First Posted: 2022-05-24
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 314

Inclusion Criteria

• Children aged 0-3 years who are going to undergo circumcision and the relatives/guardians.

Exclusion Criteria

• Children with micropenis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nursing Intervention	Intervention group	The intervention group will undergo an education program related to the circumcision process for the child's relatives/guardians.
Usual intervention	Control group	The control group will receive the usual intervention of the center.

Primary Outcome Measures

Name	Time	Method
Preoperative anxiety level of the parents	Preoperative phase	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	Intraoperatively Phase	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

Name	Time	Method
Postoperative telephone follow-up	Days 2 and 10 after the intervention.	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.

Trial Locations

Locations (1)

Policlínica Maresme; 🇪🇸 Pineda De Mar, Barcelona, Spain