Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05387291 |
| Other study ID # |
1 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2022 |
| Est. completion date |
May 22, 2022 |
Study information
| Verified date |
May 2023 |
| Source |
Universitat de Girona |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
