Pediatric CancerNCT05164354
The Effect of Cancer Therapy and Music Concert Applied to Children on Sleep
A study testing Aromatherapy and music concert in people with Pediatric Cancer and Sleep, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
The actigraph device continuously records the occurrence of limb movements and then collects the number of movements in a given time interval. Compared to polysomnography Actigraphy is a reliable and valid method for monitoring sleep in infants. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Pediatric Cancer, Sleep
- What is being tested?
- Aromatherapy and music concert
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2020to 29 Jun 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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Being oriented, open to communication and cooperation
Who cannot join
- Not in the induction phase of cancer treatment
Trial locations and contacts
1 site in 1 country.
About this study
The actigraph device continuously records the occurrence of limb movements and then collects the number of movements in a given time interval. Compared to polysomnography Actigraphy is a reliable and valid method for monitoring sleep in infants.
Read the detailed description
Cancer is a disease characterized by rapid proliferation and uncontrollable growth of abnormal cells . According to the tumor statistics data of the Turkish Pediatric Oncology Group (TPOG), the incidence of cancer in children aged 10-14 in Turkey is 22.80 per million (n= 2756), while this rate is 7.35 per million in children aged 15-19 years (n= 2756). 886). Despite the high incidence of cancer, it has started to be seen as a life-threatening chronic disease rather than a terminal disease with the treatment methods developed in the field of pediatric oncology However, early initiation of treatment, effective treatment use, and high treatment success have made increasing the quality of life and psychosocial approach even more important. However, both cancer diagnosis and treatment reduce the child's quality of life and cause many psychosocial and physical problems.
Sleep plays a role in many important functions such as growth and development, tissue regeneration, energy conservation, and strengthening of the immune system in childhood.
Inadequate sleep quality and sleep disorders are frequently observed in children diagnosed with cancer . Sleep problems are seen in approximately half of children with cancer. Difficulty falling asleep, waking up suddenly during sleep, difficulty waking up, and excessive daytime sleepiness are symptoms that indicate inadequate sleep quality in children with cancer .
Sleep problems begin with the diagnosis of children with cancer, and the amount and quality of sleep of the child is negatively affected due to reasons such as unfamiliar environment, deterioration of sleep habits, and staying away from their own bed at the first admission to the clinic. In addition, symptoms such as side effects related to the treatment initiated, disruption of sleep routine due to treatment, and pain due to illness cause sleep problems . These sleep problems make it difficult for children to comply with treatment and reduce their quality of life.
Alternative pharmacological and non-pharmacological methods can be used in the management of cancer-related sleep disorders . Aromatherapy and listening to music are among the recommended non-pharmacological methods .
Arometherapy is a therapy method that is used frequently all over the world and that explores the use of essential oils to treat and protect the health of individuals .
Music concert is one of the methods aimed at improving the health and well-being of individuals. Although it has a positive effect on children physically, psychologically, socially and emotionally, it is an economical and side-effect-free method. No studies have been found in the literature evaluating the sleep status of children with cancer with music therapy.
There are studies in which aromatherapy and music therapy are applied in children with cancer.
Although there are studies reporting that aromatherapy and music therapy are effective in relieving the symptoms of children with cancer. In this direction, there is a need for studies that compare these methods with each other and have a high level of evidence, as well as the effectiveness of aromatherapy and music therapy in children with cancer.
- Conditions
- Pediatric Cancer, Sleep
- Being tested
- Aromatherapy, music concert
- Keywords
- Pediatric cancer, sleep, aromatherapy, music concert
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AromatherapyOther
Aromatherapy: It will be applied to each child three times, three days in a row. Each application will be 20 minutes. The application time will be decided together with the patient. At the end of the three-day practice.
music concertOther
Music Concert: In this study, a music (lullaby, classical music) to be preferred by the patient or family Children are played for 20 minutes once a day. (morning or afternoon) for three days to help the child sleep. The volume of the music being played will be preserved. Aromatherapy: To be applied each child three times for three consecutive days. Each one The application will take 20 minutes. It will be time to implement The decision is made with the patient. Finally The patient's sleep quality will increase in three days of application. measured by actigraphy.
| Study group | Role | What they receive |
|---|---|---|
| Aromatherapy | Experimental | Aromatherapy will be done in the form of a 20-minute application period for three days. Receives: Other: Aromatherapy |
| music concert | Experimental | "Music concert" will be performed in the form of a 20 minute daily practice period for three days. Receives: Other: music concert |
What is being measured
The primary outcome is the main question the study is designed to answer.
Actigraphy device
The actigraph device continuously records the occurrence of limb movements and then collects the number of movements in a given time interval. Compared to polysomnography Actigraphy is a reliable and valid method for monitoring sleep in infants.
Measured: three days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2021
- Study start1 Apr 2020
- Primary completion18 May 2022
- Study completion29 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Pediatric CancerStudies of the same condition, open and under way.
- More trials run by Inonu 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- NAfter the pre-test is applied to the experimental group, music therapy and aromatherapy will be given to the experimental groups by the researcher.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Arıcıoglu Sulun, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05164354
- Sponsor's protocol ID
- 2020/165
- Status last verified
- Jan 2023
- First submitted
- 19 Nov 2021
- Last updated
- 19 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kutluk T YA. Turkish National Pediatric Cancer Registry 2002-2008. 41st Congress of International Society for Pediatric Oncology. Sao Paulo, Brazil. In: On behalf of Turkish Pediatric Oncology Group and Turkish Pediatric Hematology Society Turkish National Pediatric Cancer Registry 2002-2008 41st Congress of International Society for Pediatric Oncology Sao Paulo, Brazil. 2009. p. 851.
Kudubeş AA, Bektas M, Bektas İ, Selekoglu Y, Sal Altan S, Ayar D. The effect of symptom frequency on the fatigue and sleep quality of adolescent cancer patients. Child Heal Care. 2017;46(4):421-38.
Walter LM, Nixon GM, Davey MJ, Downie PA, Horne RS. Sleep and fatigue in pediatric oncology: A review of the literature. Sleep Med Rev. 2015 Dec;24:71-82. doi: 10.1016/j.smrv.2015.01.001. Epub 2015 Jan 13.
PubMed 25679070Kaleyias J, Manley P, Kothare SV. Sleep disorders in children with cancer. Semin Pediatr Neurol. 2012 Mar;19(1):25-34. doi: 10.1016/j.spen.2012.02.013.
PubMed 22641073Graef DM, Crabtree VM, Srivastava DK, Li C, Pritchard M, Hinds PS, Mandrell B. Sleep and mood during hospitalization for high-dose chemotherapy and hematopoietic rescue in pediatric medulloblastoma. Psychooncology. 2018 Jul;27(7):1847-1853. doi: 10.1002/pon.4737. Epub 2018 May 16.
PubMed 29663636Kushner BH, LaQuaglia MP, Wollner N, Meyers PA, Lindsley KL, Ghavimi F, Merchant TE, Boulad F, Cheung NK, Bonilla MA, Crouch G, Kelleher JF Jr, Steinherz PG, Gerald WL. Desmoplastic small round-cell tumor: prolonged progression-free survival with aggressive multimodality therapy. J Clin Oncol. 1996 May;14(5):1526-31. doi: 10.1200/JCO.1996.14.5.1526.
PubMed 8622067Allen JM, Graef DM, Ehrentraut JH, Tynes BL, Crabtree VM. Sleep and Pain in Pediatric Illness: A Conceptual Review. CNS Neurosci Ther. 2016 Nov;22(11):880-893. doi: 10.1111/cns.12583. Epub 2016 Jul 15.
PubMed 27421251American Cancer Society. Cancer Facts & Figures 2016. Cancer Facts Fig 2016. 2016;1-9.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cancer Therapy and Music Concert Applied to Children on Sleep
- ClinicalTrials.gov ID
- NCT05164354
- Acronym / sponsor ID
- 2020/165
- Conditions
- Pediatric Cancer, Sleep
- Keywords
- Pediatric cancer, sleep, aromatherapy, music concert
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 18 May 2022 (actual)
- Study completion
- 29 Jun 2022 (actual)
- First posted
- 20 Dec 2021 (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.
The actigraph device continuously records the occurrence of limb movements and then collects the number of movements in a given time interval. Compared to polysomnography Actigraphy is a reliable and valid method for monitoring sleep in infants.
Detailed description
Cancer is a disease characterized by rapid proliferation and uncontrollable growth of abnormal cells . According to the tumor statistics data of the Turkish Pediatric Oncology Group (TPOG), the incidence of cancer in children aged 10-14 in Turkey is 22.80 per million (n= 2756), while this rate is 7.35 per million in children aged 15-19 years (n= 2756). 886). Despite the high incidence of cancer, it has started to be seen as a life-threatening chronic disease rather than a terminal disease with the treatment methods developed in the field of pediatric oncology However, early initiation of treatment, effective treatment use, and high treatment success have made increasing the quality of life and psychosocial approach even more important. However, both cancer diagnosis and treatment reduce the child's quality of life and cause many psychosocial and physical problems.
Sleep plays a role in many important functions such as growth and development, tissue regeneration, energy conservation, and strengthening of the immune system in childhood.
Inadequate sleep quality and sleep disorders are frequently observed in children diagnosed with cancer . Sleep problems are seen in approximately half of children with cancer. Difficulty falling asleep, waking up suddenly during sleep, difficulty waking up, and excessive daytime sleepiness are symptoms that indicate inadequate sleep quality in children with cancer .
Sleep problems begin with the diagnosis of children with cancer, and the amount and quality of sleep of the child is negatively affected due to reasons such as unfamiliar environment, deterioration of sleep habits, and staying away from their own bed at the first admission to the clinic. In addition, symptoms such as side effects related to the treatment initiated, disruption of sleep routine due to treatment, and pain due to illness cause sleep problems . These sleep problems make it difficult for children to comply with treatment and reduce their quality of life.
Alternative pharmacological and non-pharmacological methods can be used in the management of cancer-related sleep disorders . Aromatherapy and listening to music are among the recommended non-pharmacological methods .
Arometherapy is a therapy method that is used frequently all over the world and that explores the use of essential oils to treat and protect the health of individuals .
Music concert is one of the methods aimed at improving the health and well-being of individuals. Although it has a positive effect on children physically, psychologically, socially and emotionally, it is an economical and side-effect-free method. No studies have been found in the literature evaluating the sleep status of children with cancer with music therapy.
There are studies in which aromatherapy and music therapy are applied in children with cancer.
Although there are studies reporting that aromatherapy and music therapy are effective in relieving the symptoms of children with cancer. In this direction, there is a need for studies that compare these methods with each other and have a high level of evidence, as well as the effectiveness of aromatherapy and music therapy in children with cancer.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- NAfter the pre-test is applied to the experimental group, music therapy and aromatherapy will be given to the experimental groups by the researcher.
| Arm | Type | Receives |
|---|---|---|
| Aromatherapy | Experimental | Other: AromatherapyAromatherapy will be done in the form of a 20-minute application period for three days. |
| music concert | Experimental | Other: music concert"Music concert" will be performed in the form of a 20 minute daily practice period for three days. |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Being oriented, open to communication and cooperation
Key exclusion criteria (1 listed)
- Not in the induction phase of cancer treatment
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 |
|---|---|---|
| AromatherapyAromatherapy: It will be applied to each child three times, three days in a row. Each application will be 20 minutes. The application time will be decided together with the patient. At the end of the three-day practice. | Other | Aromatherapy |
| music concertMusic Concert: In this study, a music (lullaby, classical music) to be preferred by the patient or family Children are played for 20 minutes once a day. (morning or afternoon) for three days to help the child sleep. The volume of the music being played will be preserved. Aromatherapy: To be applied each child three times for three consecutive days. Each one The application will take 20 minutes. It will be time to implement The decision is made with the patient. Finally The patient's sleep quality will increase in three days of application. measured by actigraphy. | Other | music concert |
Primary outcome
Actigraphy device
Time frame: three days
The actigraph device continuously records the occurrence of limb movements and then collects the number of movements in a given time interval. Compared to polysomnography Actigraphy is a reliable and valid method for monitoring sleep in infants.
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 Jan 2023.
- BackgroundKutluk T YA. Turkish National Pediatric Cancer Registry 2002-2008. 41st Congress of International Society for Pediatric Oncology. Sao Paulo, Brazil. In: On behalf of Turkish Pediatric Oncology Group and Turkish Pediatric Hematology Society Turkish National Pediatric Cancer Registry 2002-2008 41st Congress of International Society for Pediatric Oncology Sao Paulo, Brazil. 2009. p. 851.
- BackgroundKudubeş AA, Bektas M, Bektas İ, Selekoglu Y, Sal Altan S, Ayar D. The effect of symptom frequency on the fatigue and sleep quality of adolescent cancer patients. Child Heal Care. 2017;46(4):421-38.
- Background: PubMed 25679070Walter LM, Nixon GM, Davey MJ, Downie PA, Horne RS. Sleep and fatigue in pediatric oncology: A review of the literature. Sleep Med Rev. 2015 Dec;24:71-82. doi: 10.1016/j.smrv.2015.01.001. Epub 2015 Jan 13.
- Background: PubMed 22641073Kaleyias J, Manley P, Kothare SV. Sleep disorders in children with cancer. Semin Pediatr Neurol. 2012 Mar;19(1):25-34. doi: 10.1016/j.spen.2012.02.013.
- Background: PubMed 29663636Graef DM, Crabtree VM, Srivastava DK, Li C, Pritchard M, Hinds PS, Mandrell B. Sleep and mood during hospitalization for high-dose chemotherapy and hematopoietic rescue in pediatric medulloblastoma. Psychooncology. 2018 Jul;27(7):1847-1853. doi: 10.1002/pon.4737. Epub 2018 May 16.
- Background: PubMed 8622067Kushner BH, LaQuaglia MP, Wollner N, Meyers PA, Lindsley KL, Ghavimi F, Merchant TE, Boulad F, Cheung NK, Bonilla MA, Crouch G, Kelleher JF Jr, Steinherz PG, Gerald WL. Desmoplastic small round-cell tumor: prolonged progression-free survival with aggressive multimodality therapy. J Clin Oncol. 1996 May;14(5):1526-31. doi: 10.1200/JCO.1996.14.5.1526.
- Background: PubMed 27421251Allen JM, Graef DM, Ehrentraut JH, Tynes BL, Crabtree VM. Sleep and Pain in Pediatric Illness: A Conceptual Review. CNS Neurosci Ther. 2016 Nov;22(11):880-893. doi: 10.1111/cns.12583. Epub 2016 Jul 15.
- Results publicationAmerican Cancer Society. Cancer Facts & Figures 2016. Cancer Facts Fig 2016. 2016;1-9.
- Individual participant dataSharing planned: No
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Knowledge, Attitudes, Practice
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 Aromatherapy and music concert in people with Pediatric Cancer and Sleep, run by Inonu University at 1 site in Turkey (Türkiye).
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 Jan 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 Turkey (Türkiye). 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?
Actigraphy device (time frame: three days). 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 NCT05164354, which also lists 8 linked publications.
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 Jan 2023.