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

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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Anxiety; Child Development
• Intervention / Treatment: Behavioral: Intervention group; Behavioral: Control group

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 Type: Interventional
• Enrollment (Actual): 314
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Pineda De Mar, Barcelona, Spain, 08397
      • Policlínica Maresme

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 90 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Children with micropenis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nursing Intervention; The intervention group will undergo an education program related to the circumcision process for the child's relatives/guardians.	Behavioral: Intervention group; The intervention group will undergo an education program related to the circumcision process for the child's relatives/guardians.
Other: Usual intervention; The control group will receive the usual intervention of the center.	Behavioral: Control group; The control group will receive the usual intervention of the center.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Preoperative phase
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.	Intraoperatively Phase

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Days 2 and 10 after the intervention.

Collaborators and Investigators

• Sponsor: Universitat de Girona

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): March 12, 2022
• Study Completion (Actual): May 22, 2022

Study Registration Dates

• First Submitted: May 12, 2022
• First Submitted That Met QC Criteria: May 18, 2022
• First Posted (Actual): May 24, 2022

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Pain; Anxiety; Child Preschool; Circumcision Male
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Anxiety Disorders
• Other Study ID Numbers: 1 (Other Identifier: Mobile Health and Wellness Program)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data will only be used by the study investigators.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No