AnxietyNCT05387291
Nursing Intervention Program in the Management of Parental Anxiety and Infant Pain in the Surgical Process of Children to be Circumcised
A study testing Intervention group in people with Anxiety and Pain, Postoperative, run by Universitat de Girona at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 0 months to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Pain, Postoperative, Child Development
- What is being tested?
- Intervention group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 314 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2022to 22 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 months to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Children aged 0-3 years who are going to undergo circumcision and the relatives/guardians.
Who cannot join
- Children with micropenis
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Anxiety, Pain, Postoperative, Child Development
- Being tested
- Intervention group, Control group
- Keywords
- Anxiety, Child Preschool, Circumcision Male, Pain
- Medical subject headings
- Anxiety Disorders, Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention groupBehavioural
The intervention group will undergo an education program related to the circumcision process for the child's relatives/guardians.
Control groupBehavioural
The control group will receive the usual intervention of the center.
| Study group | Role | What they receive |
|---|---|---|
| Nursing Intervention | Experimental | The intervention group will undergo an education program related to the circumcision process for the child's relatives/guardians. Receives: Behavioral: Intervention group |
| Usual intervention | Other | The control group will receive the usual intervention of the center. Receives: Behavioral: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Intraoperatively Phase
Secondary outcomes (1)
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.
Measured: Days 2 and 10 after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start1 Feb 2022
- Primary completion12 Mar 2022
- Study completion22 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomly assigned to one group (intervention) or the other (control).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 314 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat de Girona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lyudmila Andrusenko Kalchenko, Universitat de Girona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05387291
- Sponsor's protocol ID
- 1
- Status last verified
- May 2023
- First submitted
- 12 May 2022
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will only be used by the study investigators.
Publications
Andrusenko-Kalchenko L, Romero-Collado A, Ballester-Ferrando D, Sanvicens A, Zabaleta-Del-Olmo E, Rascon-Hernan C. Nurse-Led Intervention to Reduce Parental Anxiety and Child Pain During Non-Therapeutic Male Circumcision: A Randomized Trial. SAGE Open Nurs. 2026 Apr 10;12:23779608261442615. doi: 10.1177/23779608261442615. eCollection 2026 Jan-Dec.
PubMed 41978788
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05387291
- Acronym / sponsor ID
- 1
- Conditions
- Anxiety, Pain, Postoperative, Child Development
- Keywords
- Anxiety, Child Preschool, Circumcision Male, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 314 participants (actual)
- Lead sponsor
- Universitat de GironaUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 12 Mar 2022 (actual)
- Study completion
- 22 May 2022 (actual)
- First posted
- 24 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Subjects will be randomly assigned to one group (intervention) or the other (control).
| Arm | Type | Receives |
|---|---|---|
| Nursing Intervention | Experimental | Behavioral: Intervention groupThe intervention group will undergo an education program related to the circumcision process for the child's relatives/guardians. |
| Usual intervention | Other | Behavioral: Control groupThe control group will receive the usual intervention of the center. |
Who may qualify
- Ages
- 0 months to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Children aged 0-3 years who are going to undergo circumcision and the relatives/guardians.
Key exclusion criteria (1 listed)
- Children with micropenis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention groupThe intervention group will undergo an education program related to the circumcision process for the child's relatives/guardians. | Behavioural | Nursing Intervention |
| Control groupThe control group will receive the usual intervention of the center. | Behavioural | Usual intervention |
Primary outcome
Preoperative anxiety level of the parents
Time frame: 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
Time frame: 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.
1 secondary outcome
Postoperative telephone follow-up
Time frame: Days 2 and 10 after the intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Derived from this study: PubMed 41978788Andrusenko-Kalchenko L, Romero-Collado A, Ballester-Ferrando D, Sanvicens A, Zabaleta-Del-Olmo E, Rascon-Hernan C. Nurse-Led Intervention to Reduce Parental Anxiety and Child Pain During Non-Therapeutic Male Circumcision: A Randomized Trial. SAGE Open Nurs. 2026 Apr 10;12:23779608261442615. doi: 10.1177/23779608261442615. eCollection 2026 Jan-Dec.
- Individual participant dataSharing planned: No. The data will only be used by the study investigators.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group in people with Anxiety and Pain, Postoperative, run by Universitat de Girona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative anxiety level of the parents (time frame: Preoperative phase). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05387291, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.