Nursing Intervention Program in the Management of Parental Anxiety and Infant Pain in the Surgical Process of Children to be Circumcised
Condition: Anxiety; Pain, Postoperative; Child Development
MeSH terms: Pain, Postoperative; Anxiety Disorders
Study type: Interventional

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.
    

Intervention name(s): Intervention group; Control group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be randomly assigned to one group (intervention) or the other (control).
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Anxiety; Child Preschool; Circumcision Male; Pain