Intraoperative AwarenessNCT02583295
The Impact of Maternal Sound on Awareness for Pediatric Patients Undergoing Cardiac Surgery
A study testing Music sound and Maternal sound in people with Intraoperative Awareness, run by Assiut University at 1 site in Egypt.
Trial summary
Awareness during anesthesia with intraoperative memory occurs when the patient is able to process information and produce specific responses to several stimuli. Anecdotal evidence suggests that children exposed to therapeutic suggestion consisting of gently encouraging, positive words spoken to them during emergence… Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Intraoperative Awareness
- What is being tested?
- Music sound and Maternal sound
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 309 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2016to Sep 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 4 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- patients in the age range 4-8 years scheduled for elective cardiac surgery for Atrial Septal Defect (ASD) repair with Cardiopulmonary bypass
Who cannot join
- Patients with previous cardiac surgery, diabetes mellitus, hearing impairment and psychiatric or neurological illness were excluded from this study.
Trial locations and contacts
1 site in 1 country.
About this study
Awareness during anesthesia with intraoperative memory occurs when the patient is able to process information and produce specific responses to several stimuli. Anecdotal evidence suggests that children exposed to therapeutic suggestion consisting of gently encouraging, positive words spoken to them during emergence from anesthesia seem to arouse after surgery with less agitation, less pain and lower requirements for pain medications. Therapeutic suggestion has been associated with positive results in some adults during surgery, but it is unknown how therapeutic suggestion affects children. A newborn's recognition and preference for their mother's voice occurs early in life, very likely during fetal development. Additional evidence, revealed that at least as early as 4 months of age, infants process auditory stimuli from their mother's voice at a higher amplitude than they process auditory input from female strangers, suggesting that maternal voice stimuli undergo a unique form of cerebral processing that lends support for the existence of neurophysiologic mechanisms that reflect a child's preference for his/her mother's voice. This study aims to evaluate and compare the possibility of intra-operative awareness prevention by using either music listening or maternal sound listening in children undergoing cardiac surgery.
Read the detailed description
children (4 to 8 years) undergoing repair of Atrial Septal Defect (ASD). Patients will be randomized into two groups (music group and maternal sound group); in music group patients listened to a recorded CD by music and songs preferred by the child, while in maternal sound group patients listened to a recorded CD where the mother singing the most popular songs their children like or telling a story to their children. In both groups bi spectral index (BIS) to detect depth of anesthesia. An interview will be conducted with the patients and their parent within the first postoperative week by a semi-structured in-depth questionnaire to evaluate occurrence of awareness.
- Conditions
- Intraoperative Awareness
- Being tested
- Music sound, Maternal sound
- Keywords
- Awareness, Cardiac Surgery, Maternal, Pediatric, Sound, Music
- Medical subject headings
- Intraoperative Awareness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music soundBehavioural
The recorded preferred songs or music (commercially available) listened by CD player connected to the patient ears before induction of anesthesia and continued during intra operative period
Maternal soundBehavioural
The recorded maternal voice (while they are singing the most popular songs their children like or telling a story to help their children to sleep) listened by CD player connected to the patient ears before induction of anesthesia and continued during intra operative period
| Study group | Role | What they receive |
|---|---|---|
| Music group | Active comparator | Music sound Receives: Behavioral: Music sound |
| Maternal sound group | Active comparator | Maternal sound Receives: Behavioral: Maternal sound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative awareness
by using a semi-structured in-depth questionnaire (a qualitative method adapted to assess memory development and language level in children to encourage their recall quality and reduce their suggestibility)
Measured: within the first 24 hours during surgery
Secondary outcomes (7)
Duration of mechanical ventilation
duration of postoperative mechanical ventilation reported in hours
Measured: within the first 30 days after surgery
postoperative cardiac ICU stay
length of stay in the postoperative cardiac ICU (days)
Measured: within the first 30 days after surgery
hospital stay
length of stay in the hospital (days)
Measured: within the first 30 days after surgery
changes from baseline serum cortisol at postoperative period
changes from baseline serum cortisol at postoperative period
Measured: Within the first 7 days postoperative
changes from baseline blood sugar at postoperative period
changes from baseline blood sugar at postoperative period
Measured: Within the first 7 days postoperative
child post-traumatic stress disorder (PTSD)
child post-traumatic stress disorder (PTSD) by special scale questionnaire
Measured: Within the first 7 days postoperative
changes in behavior
changes in physiological and psychosocial behaviors of children by questionnaire
Measured: Within the first 7 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2015 (estimated)
- Study start15 Jun 2016
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative AwarenessStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 309 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sayed Kaoud Abd-Elshafy, Assiut University
- Investigators
- sayed abd elshafy, MD, Principal investigator, associate professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02583295
- Sponsor's protocol ID
- IRB000087135
- Status last verified
- Oct 2017
- First submitted
- 10 Oct 2015
- Last updated
- 19 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Maternal Sound on Awareness for Pediatric Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02583295
- Acronym / sponsor ID
- IRB000087135
- Conditions
- Intraoperative Awareness
- Keywords
- Awareness, Cardiac Surgery, Maternal, Pediatric, Sound, Music
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 309 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Jun 2016 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 22 Oct 2015 (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.
Awareness during anesthesia with intraoperative memory occurs when the patient is able to process information and produce specific responses to several stimuli. Anecdotal evidence suggests that children exposed to therapeutic suggestion consisting of gently encouraging, positive words spoken to them during emergence from anesthesia seem to arouse after surgery with less agitation, less pain and lower requirements for pain medications. Therapeutic suggestion has been associated with positive results in some adults during surgery, but it is unknown how therapeutic suggestion affects children. A newborn's recognition and preference for their mother's voice occurs early in life, very likely during fetal development. Additional evidence, revealed that at least as early as 4 months of age, infants process auditory stimuli from their mother's voice at a higher amplitude than they process auditory input from female strangers, suggesting that maternal voice stimuli undergo a unique form of cerebral processing that lends support for the existence of neurophysiologic mechanisms that reflect a child's preference for his/her mother's voice. This study aims to evaluate and compare the possibility of intra-operative awareness prevention by using either music listening or maternal sound listening in children undergoing cardiac surgery.
Detailed description
children (4 to 8 years) undergoing repair of Atrial Septal Defect (ASD). Patients will be randomized into two groups (music group and maternal sound group); in music group patients listened to a recorded CD by music and songs preferred by the child, while in maternal sound group patients listened to a recorded CD where the mother singing the most popular songs their children like or telling a story to their children. In both groups bi spectral index (BIS) to detect depth of anesthesia. An interview will be conducted with the patients and their parent within the first postoperative week by a semi-structured in-depth questionnaire to evaluate occurrence of awareness.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music group | Active comparator | Behavioral: Music soundMusic sound |
| Maternal sound group | Active comparator | Behavioral: Maternal soundMaternal sound |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- patients in the age range 4-8 years scheduled for elective cardiac surgery for Atrial Septal Defect (ASD) repair with Cardiopulmonary bypass
Key exclusion criteria (1 listed)
- Patients with previous cardiac surgery, diabetes mellitus, hearing impairment and psychiatric or neurological illness were excluded from this study.
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 |
|---|---|---|
| Music soundThe recorded preferred songs or music (commercially available) listened by CD player connected to the patient ears before induction of anesthesia and continued during intra operative period | Behavioural | Music group |
| Maternal soundThe recorded maternal voice (while they are singing the most popular songs their children like or telling a story to help their children to sleep) listened by CD player connected to the patient ears before induction of anesthesia and continued during intra operative period | Behavioural | Maternal sound group |
Primary outcome
Intraoperative awareness
Time frame: within the first 24 hours during surgery
by using a semi-structured in-depth questionnaire (a qualitative method adapted to assess memory development and language level in children to encourage their recall quality and reduce their suggestibility)
7 secondary outcomes
Duration of mechanical ventilation
Time frame: within the first 30 days after surgery
postoperative cardiac ICU stay
Time frame: within the first 30 days after surgery
hospital stay
Time frame: within the first 30 days after surgery
changes from baseline serum cortisol at postoperative period
Time frame: Within the first 7 days postoperative
changes from baseline blood sugar at postoperative period
Time frame: Within the first 7 days postoperative
child post-traumatic stress disorder (PTSD)
Time frame: Within the first 7 days postoperative
changes in behavior
Time frame: Within the first 7 days postoperative
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 19 Oct 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Intraoperative Awareness
Not yet recruitingObservational study
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Evaluation of Intraoperative Awareness and Its Correlation With Processed EEG Biomarkers During Laparoscopic Surgery
Intraoperative Awareness, Intraoperative Responsiveness During General Anesthesia
Recruiting
Trajectories of Recovery After Intravenous Propofol Versus Inhaled VolatilE Anesthesia Trial
Surgery-Complications, Anesthesia Complication
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Fear and Anxiety in Anesthesia-Naïve Patients Pre-operatively vs Post-operatively
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Not yet recruitingObservational study
Deep Learning Framework for Continuous Depth of Anesthesia Forecasting
BIS, BIS-EEG
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.
sayed abd elshafy, MD principal investigator
associate professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music sound and Maternal sound in people with Intraoperative Awareness, run by Assiut University at 1 site in Egypt.
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 19 Oct 2017. 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 Egypt. 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?
Intraoperative awareness (time frame: within the first 24 hours during surgery). 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 19 Oct 2017.