CircumcisionNCT01909609
Parents' Knowledge and Perception of Benefits and Risks Regarding Neonatal Circumcision
A study testing AAP Documents and Parent Survival Guide in people with Circumcision, run by University of Michigan at 1 site in United States.
Trial summary
The American Academy of Pediatrics changed their stance on circumcision to "health benefits of newborn male circumcision outweigh the risks and that the procedure's benefits justify access to this procedure for families who choose it" (AAP, 2012). We wonder if parents are aware of guidelines such as those of the AAP. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Circumcision
- What is being tested?
- AAP Documents and Parent Survival Guide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 680 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to 16 Jun 2017
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects will be recruited from the Obstetrics clinic. All expectant parents of children are eligible to participate in this study. The study team will include those who do not know the sex of their baby and later exclude those who ultimately have girls from the final survey.
Who cannot join
- Exclusion is limited to parents with a child that has had a genital anomaly identified via ultrasound before the time of the research study, and parents that definitively know they are having girls.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Health System
Ann Arbor, Michigan, 48109
About this study
The American Academy of Pediatrics changed their stance on circumcision to "health benefits of newborn male circumcision outweigh the risks and that the procedure's benefits justify access to this procedure for families who choose it" (AAP, 2012).
We wonder if parents are aware of guidelines such as those of the AAP. Are parents able to make this medical decision by weighing the risks against the benefits of circumcision, or do they simply use sociocultural/religious reasons to make this decision? We hypothesize that parents are unaware of the specific benefits and risks of circumcision, and make this decision based primarily on sociocultural, religious, and/or familial norms.
Read more
Expectant parents' knowledge will be assessed via a Qualtrics survey. Participants will be recruited in the OB/GYN clinic sometime between their 24-28 week prenatal visit. We hope to accrue at least 680 participants for this study in order to achieve statistical significance and acquire a range of demographics. Expectant mothers and fathers (and single mothers) will be encouraged to participate.
This survey will assess their desire to get their child circumcised when they are born. Participants will be asked to list perceived risks and benefits of circumcision. This will hopefully allow us to see two things: if parents are aware and knowledgeable of the risks and benefits or circumcision, and what they perceive to be risky or beneficial from a medical standpoint.
Parents will be randomly given 1 of 2 pieces of information (1 per couple [or per single mother]; 1 control, 1 experiment) with different information about circumcision. We will see if there are any outcome differences based on which group the couple randomized into. Follow-up phone call will serve to assess outcome if baby was circumcised and any factors that led up to the decision. This will allow us to see if the AAP stance has any effect on decision making when we compare the control and experiment groups.
- Conditions
- Circumcision
- Being tested
- AAP Documents, Parent Survival Guide
- Keywords
- male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AAP DocumentsOther
Parent Survival GuideOther
| Study group | Role | What they receive |
|---|---|---|
| Parent Survival Guide | Sham comparator | This arm of the study will focus on the document that is normally given to all parents of newborn infants. It contains information on newborn care such as feeding, cleaning of the baby's penis, etc. Receives: Other: Parent Survival Guide |
| AAP Documents + Parent Survival Guide. | Experimental | This arm of the study will focus on documents created based off of the American Academy of Pediatrics 2012 policy statement. They contain information on the potential risks and benefits of neonatal circumcision. The Parent Survival Guide contains information on newborn care such as feeding, cleaning of the baby's penis, etc. Receives: Other: AAP Documents; Other: Parent Survival Guide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of children circumcised
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2013 (estimated)
- Study startJul 2013
- Primary completion16 Jun 2017
- Study completion16 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CircumcisionStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 680 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Eickmeyer, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01909609
- Sponsor's protocol ID
- HUM00073478
- Status last verified
- Aug 2019
- First submitted
- 24 Jul 2013
- Last updated
- 5 Aug 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parents' Knowledge and Perception of Benefits and Risks Regarding Neonatal Circumcision
- ClinicalTrials.gov ID
- NCT01909609
- Acronym / sponsor ID
- HUM00073478
- Conditions
- Circumcision
- Keywords
- male
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 680 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Jul 2013 (actual)
- Primary completion
- 16 Jun 2017 (actual)
- Study completion
- 16 Jun 2017 (actual)
- First posted
- 26 Jul 2013 (estimated)
- 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.
The American Academy of Pediatrics changed their stance on circumcision to "health benefits of newborn male circumcision outweigh the risks and that the procedure's benefits justify access to this procedure for families who choose it" (AAP, 2012).
We wonder if parents are aware of guidelines such as those of the AAP. Are parents able to make this medical decision by weighing the risks against the benefits of circumcision, or do they simply use sociocultural/religious reasons to make this decision? We hypothesize that parents are unaware of the specific benefits and risks of circumcision, and make this decision based primarily on sociocultural, religious, and/or familial norms.
Expectant parents' knowledge will be assessed via a Qualtrics survey. Participants will be recruited in the OB/GYN clinic sometime between their 24-28 week prenatal visit. We hope to accrue at least 680 participants for this study in order to achieve statistical significance and acquire a range of demographics. Expectant mothers and fathers (and single mothers) will be encouraged to participate.
This survey will assess their desire to get their child circumcised when they are born. Participants will be asked to list perceived risks and benefits of circumcision. This will hopefully allow us to see two things: if parents are aware and knowledgeable of the risks and benefits or circumcision, and what they perceive to be risky or beneficial from a medical standpoint.
Parents will be randomly given 1 of 2 pieces of information (1 per couple [or per single mother]; 1 control, 1 experiment) with different information about circumcision. We will see if there are any outcome differences based on which group the couple randomized into. Follow-up phone call will serve to assess outcome if baby was circumcised and any factors that led up to the decision. This will allow us to see if the AAP stance has any effect on decision making when we compare the control and experiment groups.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parent Survival Guide | Sham comparator | Other: Parent Survival GuideThis arm of the study will focus on the document that is normally given to all parents of newborn infants. It contains information on newborn care such as feeding, cleaning of the baby's penis, etc. |
| AAP Documents + Parent Survival Guide. | Experimental | Other: AAP Documents, Other: Parent Survival GuideThis arm of the study will focus on documents created based off of the American Academy of Pediatrics 2012 policy statement. They contain information on the potential risks and benefits of neonatal circumcision. The Parent Survival Guide contains information on newborn care such as feeding, cleaning of the baby's penis, etc. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects will be recruited from the Obstetrics clinic. All expectant parents of children are eligible to participate in this study. The study team will include those who do not know the sex of their baby and later exclude those who ultimately have girls from the final survey.
Key exclusion criteria (1 listed)
- Exclusion is limited to parents with a child that has had a genital anomaly identified via ultrasound before the time of the research study, and parents that definitively know they are having girls.
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 |
|---|---|---|
| AAP Documents | Other | AAP Documents + Parent Survival Guide. |
| Parent Survival Guide | Other | AAP Documents + Parent Survival Guide., Parent Survival Guide |
Primary outcome
Number of children circumcised
Time frame: 18 weeks
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 5 Aug 2019.
Related trials for Circumcision
Not yet recruitingObservational study
Preoperative Fasting and Perioperative Outcomes in Children Undergoing Elective Circumcision
Preoperative Fasting, Perioperative Anxiety
Active, not recruiting
A Study Comparing The Effect Of Local Application Of Polyfax Versus Coconut Oil On Outcome Of Plastibell Circumcision In A Tertiary Care Hospital
Circumcision, Male
Not yet recruiting
Effects of Therapeutic Touch and Music on Children's Anxiety, Pain, and Nausea Before and After Circumcision
Circumcision
Not yet recruitingPhase 2
Efficacy and Safety of Circumcision Alone on Risk of Febrile Urinary Tract Infections in Boys With Posterior Urethral Valves: a Prospective Randomized Open-label Multicentric Trial Enriched With Historic Controls.
Posterior Urethral Valves
Recruiting
Compared Reversed US-Guided Dorsal Penile Nerve Block (RUSDPNB) With DPNB in Circumcisions for Pediatric Patients
Circumcision, Ultrasound
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 AAP Documents and Parent Survival Guide in people with Circumcision, run by University of Michigan at 1 site in United States.
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 5 Aug 2019. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Number of children circumcised (time frame: 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Aug 2019.