Pediatric CancerNCT04651608
The Effect of Acupressure Chemotherapy-related Nausea Vomiting in Children
A study testing manuel acupressure and sea-band acupressure in people with Pediatric Cancer and Nausea With Vomiting Chemotherapy-Induced, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
This study is carried out to evaluate and compare the efficiency of acupressure practice applied with pressure or sea-band and their placebo on managing the acute nausea-vomiting symptoms developing due to chemotherapy in pediatric oncology patients. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Pediatric Cancer, Nausea With Vomiting Chemotherapy-Induced
- What is being tested?
- manuel acupressure and sea-band acupressure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2017to 1 Mar 2018
- 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children between the ages of 5-18,
- Who have a chemotherapy protocol with a high and moderate emetogenic effect according to MASCC / ESMO Antiemetic Guidance Classification
- Not having a verbal communication disorder.
Who cannot join
- If the participants did not receive chemotherapy or were receiving it for the first time,
- Branching, redness, phlebitis, edema, open wound, fracture, infection, etc. in the wrist
- Any obstacles for the verbal assessment of the child (intubation, etc.).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Acupress in The Management of Chemotherapy-Developed Acute Nausea Vomiting Symptoms In Child Oncology Patients
This study is carried out to evaluate and compare the efficiency of acupressure practice applied with pressure or sea-band and their placebo on managing the acute nausea-vomiting symptoms developing due to chemotherapy in pediatric oncology patients.
Read the detailed description
Every year children aged 0 to 19 years old are diagnosed with cancer around the world. For pediatric oncology patients, chemotherapy-related acute nausea and vomiting are among most common symptoms and has a bad influence on quality of life. When it cannot be prevented, it can cause serious medical problems. Continuous, repetitive and unavoidable vomiting affects patients' and their families' quality of life adversely, causing delay or even termination in chemotherapy treatment. It is a well-known fact that medical treatment is insufficient to control nausea and vomiting symptoms. Therefore, supportive care is needed besides medical treatment. One of the approaches mentioned is acupressure. Non-invasive stimulation of the P6 acupuncture point is a harmless and complementary approach to health. The point between flexor carpi radialis and palmaris longus, located at a three finger distance from the wrist crease, is named as "P6 Nei-Guan". This acupuncture point, placed on the pericardium channel, is generally used to harmonize stomach and relieve the vomiting. Acupressure is a way of stimulation applied on acupuncture points by finger, palm or acustimulation bands (sea-band, relief band) and can be used for children as well. Acupressure is defined as one of the complementary health approaches which nurses can apply. It is stated that this method, which is non-invasive, economical, easy to apply and reliable, has no side effect and patients can apply to themselves with a good guidance.
Chemotherapy-related nausea and vomiting are among the symptoms affecting children's quality of life and their adaptation to the treatment. There are limited amount of research intended to manage pediatric oncology patients' chemotherapy-related nausea and vomiting symptoms by using acupressure. It is thought that the research will provide significant contribution for literature, nursing practice and the quality of patient care since power of the study is high and it is the first study which efficiency of wrist-band, manuel acupressure and placebos is being compared for management of chemotherapy-related acute nausea and vomiting symptoms in pediatric oncology patients.
- Being tested
- manuel acupressure, sea-band acupressure, placebo manuel acupressure, placebo sea-band
- Keywords
- nursing, child cancer patients, acupressure, Nausea with Vomiting Chemotherapy-Induced, nausea and vomiting, pediatric cancer
- Medical subject headings
- Neoplasms, Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
manuel acupressureBehavioural
Acupressure was applied once by the researcher 30 minutes before applying the chemotherapeutic agent with medium or high emetogenicity to the randomized child. 3 fingers were placed on the child's wrist with their fingers and the region (point P6) between the flexor carpi radians and palmaris longus 1 cm below. Acupressure was applied to the wrist of the child by press for 2 minutes. The same procedure was applied to the other wrist. Then, data were recorded in accordance with the data collection procedure.
sea-band acupressureBehavioural
30 minutes before applying the chemotherapeutic agent with medium or high emetogenicity to the randomized child, sea-band acupress was applied by the researcher. The P6 point on the wrist was identified and marked with the child's own fingers. A sea band was attached to both wrists of the child by the researcher. The attached sea-band was allowed to remain for 15 minutes and was removed by the researcher at the end of the period. Separate sea-band was attached to each child. Acupress wrist bands, which are produced in separate sizes for adults and children, were used during the application, taking into account the physical development of the child, pediatric for the age range of 5-12, and adult size sea-band for the age of 12. Acupress application with sea-band was done once. Then, data were recorded in accordance with the data collection procedure
placebo manuel acupressureBehavioural
Placebo manual acupress was applied in the next protocol for the child who was administered manual acupressure.
placebo sea-bandBehavioural
Placebo sea-band was applied in the next protocol for the child who was administered sea-band acupressure.
| Study group | Role | What they receive |
|---|---|---|
| manuel acupressure | Experimental | In this group, manual acupress was applied to children receiving chemotherapy with moderate and high emetogenic effects. Receives: Behavioral: manuel acupressure; Behavioral: placebo manuel acupressure |
| sea-band acupressure | Experimental | In this group, sea-band acupressure was applied to children receiving chemotherapy with moderate and high emetogenic effects. Receives: Behavioral: sea-band acupressure; Behavioral: placebo sea-band |
What is being measured
The primary outcome is the main question the study is designed to answer.
number and severity of nausea, number and severity of vomiting
Following the interventions, the number of nausea and vomiting experienced by children was followed up for 24 hours. visual severity scale was used to score nausea and vomiting severity. (numeric expression, VAS, 0-10)
Measured: during study
Secondary outcomes (1)
antiemetic need
The antiemetic drugs needed by children were recorded for 24 hours after the interventions. (numeric expression, 0-10)
Measured: during study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start1 Mar 2017
- Primary completion6 Jun 2017
- Study completion1 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 Akdeniz 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
- Factorial
- Model description
- One of the 2 procedure groups randomized with sealed envelope was applied acupressure with pressure to the P-6 point on the wrist of the child by the researcher in the first application, the other is applied with sea-band, and it was followed for 24 hours. Acupressure application was performed on both wrists for 2 minutes each with pressure, and 15 minutes each with sea-band. In the next chemotherapy treatment, a placebo of the first procedure (placebo pressure/placebo sea-band) was applied to each child, which ensured the control group of their own.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duygu ALTUNTAŞ BALCI, Akdeniz University
- Investigators
- Aysegül İŞLER DALGIÇ, Professor, Study director, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04651608
- Sponsor's protocol ID
- TYL-2016-1099
- Other IDs
- TYL-2016-1099
- Status last verified
- Mar 2021
- First submitted
- 21 Jul 2020
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data sharing plans for the current study are unknown and will be made available at a later date.
Publications
Dupuis LL, Kelly KM, Krischer JP, Langevin AM, Tamura RN, Xu P, Chen L, Kolb EA, Ullrich NJ, Sahler OJZ, Hendershot E, Stratton A, Sung L, McLean TW. Acupressure bands do not improve chemotherapy-induced nausea control in pediatric patients receiving highly emetogenic chemotherapy: A single-blinded, randomized controlled trial. Cancer. 2018 Mar 15;124(6):1188-1196. doi: 10.1002/cncr.31198. Epub 2017 Dec 19.
PubMed 29266260Jones E, Isom S, Kemper KJ, McLean TW. Acupressure for chemotherapy-associated nausea and vomiting in children. J Soc Integr Oncol. 2008 Fall;6(4):141-5.
PubMed 19134445Miao J, Liu X, Wu C, Kong H, Xie W, Liu K. Effects of acupressure on chemotherapy-induced nausea and vomiting-a systematic review with meta-analyses and trial sequential analysis of randomized controlled trials. Int J Nurs Stud. 2017 May;70:27-37. doi: 10.1016/j.ijnurstu.2017.02.014. Epub 2017 Feb 14.
PubMed 28231440
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Acupress in The Management of Chemotherapy-Developed Acute Nausea Vomiting Symptoms In Child Oncology Patients
- ClinicalTrials.gov ID
- NCT04651608
- Acronym / sponsor ID
- TYL-2016-1099
- Keywords
- nursing, child cancer patients, acupressure, Nausea with Vomiting Chemotherapy-Induced, nausea and vomiting, pediatric cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 6 Jun 2017 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 3 Dec 2020 (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.
This study is carried out to evaluate and compare the efficiency of acupressure practice applied with pressure or sea-band and their placebo on managing the acute nausea-vomiting symptoms developing due to chemotherapy in pediatric oncology patients.
Detailed description
Every year children aged 0 to 19 years old are diagnosed with cancer around the world. For pediatric oncology patients, chemotherapy-related acute nausea and vomiting are among most common symptoms and has a bad influence on quality of life. When it cannot be prevented, it can cause serious medical problems. Continuous, repetitive and unavoidable vomiting affects patients' and their families' quality of life adversely, causing delay or even termination in chemotherapy treatment. It is a well-known fact that medical treatment is insufficient to control nausea and vomiting symptoms. Therefore, supportive care is needed besides medical treatment. One of the approaches mentioned is acupressure. Non-invasive stimulation of the P6 acupuncture point is a harmless and complementary approach to health. The point between flexor carpi radialis and palmaris longus, located at a three finger distance from the wrist crease, is named as "P6 Nei-Guan". This acupuncture point, placed on the pericardium channel, is generally used to harmonize stomach and relieve the vomiting. Acupressure is a way of stimulation applied on acupuncture points by finger, palm or acustimulation bands (sea-band, relief band) and can be used for children as well. Acupressure is defined as one of the complementary health approaches which nurses can apply. It is stated that this method, which is non-invasive, economical, easy to apply and reliable, has no side effect and patients can apply to themselves with a good guidance.
Chemotherapy-related nausea and vomiting are among the symptoms affecting children's quality of life and their adaptation to the treatment. There are limited amount of research intended to manage pediatric oncology patients' chemotherapy-related nausea and vomiting symptoms by using acupressure. It is thought that the research will provide significant contribution for literature, nursing practice and the quality of patient care since power of the study is high and it is the first study which efficiency of wrist-band, manuel acupressure and placebos is being compared for management of chemotherapy-related acute nausea and vomiting symptoms in pediatric oncology patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- One of the 2 procedure groups randomized with sealed envelope was applied acupressure with pressure to the P-6 point on the wrist of the child by the researcher in the first application, the other is applied with sea-band, and it was followed for 24 hours. Acupressure application was performed on both wrists for 2 minutes each with pressure, and 15 minutes each with sea-band. In the next chemotherapy treatment, a placebo of the first procedure (placebo pressure/placebo sea-band) was applied to each child, which ensured the control group of their own.
| Arm | Type | Receives |
|---|---|---|
| manuel acupressure | Experimental | Behavioral: manuel acupressure, Behavioral: placebo manuel acupressureIn this group, manual acupress was applied to children receiving chemotherapy with moderate and high emetogenic effects. |
| sea-band acupressure | Experimental | Behavioral: sea-band acupressure, Behavioral: placebo sea-bandIn this group, sea-band acupressure was applied to children receiving chemotherapy with moderate and high emetogenic effects. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Children between the ages of 5-18,
- Who have a chemotherapy protocol with a high and moderate emetogenic effect according to MASCC / ESMO Antiemetic Guidance Classification
- Not having a verbal communication disorder.
Key exclusion criteria (3 listed)
- If the participants did not receive chemotherapy or were receiving it for the first time,
- Branching, redness, phlebitis, edema, open wound, fracture, infection, etc. in the wrist
- Any obstacles for the verbal assessment of the child (intubation, etc.).
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 |
|---|---|---|
| manuel acupressureAcupressure was applied once by the researcher 30 minutes before applying the chemotherapeutic agent with medium or high emetogenicity to the randomized child. 3 fingers were placed on the child's wrist with their fingers and the region (point P6) between the flexor carpi radians and palmaris longus 1 cm below. Acupressure was applied to the wrist of the child by press for 2 minutes. The same procedure was applied to the other wrist. Then, data were recorded in accordance with the data collection procedure. | Behavioural | manuel acupressure |
| sea-band acupressure30 minutes before applying the chemotherapeutic agent with medium or high emetogenicity to the randomized child, sea-band acupress was applied by the researcher. The P6 point on the wrist was identified and marked with the child's own fingers. A sea band was attached to both wrists of the child by the researcher. The attached sea-band was allowed to remain for 15 minutes and was removed by the researcher at the end of the period. Separate sea-band was attached to each child. Acupress wrist bands, which are produced in separate sizes for adults and children, were used during the application, taking into account the physical development of the child, pediatric for the age range of 5-12, and adult size sea-band for the age of 12. Acupress application with sea-band was done once. Then, data were recorded in accordance with the data collection procedure | Behavioural | sea-band acupressure |
| placebo manuel acupressurePlacebo manual acupress was applied in the next protocol for the child who was administered manual acupressure. | Behavioural | manuel acupressure |
| placebo sea-bandPlacebo sea-band was applied in the next protocol for the child who was administered sea-band acupressure. | Behavioural | sea-band acupressure |
Primary outcome
number and severity of nausea, number and severity of vomiting
Time frame: during study
Following the interventions, the number of nausea and vomiting experienced by children was followed up for 24 hours. visual severity scale was used to score nausea and vomiting severity. (numeric expression, VAS, 0-10)
1 secondary outcome
antiemetic need
Time frame: during study
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 3 Mar 2021.
- Background: PubMed 29266260Dupuis LL, Kelly KM, Krischer JP, Langevin AM, Tamura RN, Xu P, Chen L, Kolb EA, Ullrich NJ, Sahler OJZ, Hendershot E, Stratton A, Sung L, McLean TW. Acupressure bands do not improve chemotherapy-induced nausea control in pediatric patients receiving highly emetogenic chemotherapy: A single-blinded, randomized controlled trial. Cancer. 2018 Mar 15;124(6):1188-1196. doi: 10.1002/cncr.31198. Epub 2017 Dec 19.
- Background: PubMed 19134445Jones E, Isom S, Kemper KJ, McLean TW. Acupressure for chemotherapy-associated nausea and vomiting in children. J Soc Integr Oncol. 2008 Fall;6(4):141-5.
- Background: PubMed 28231440Miao J, Liu X, Wu C, Kong H, Xie W, Liu K. Effects of acupressure on chemotherapy-induced nausea and vomiting-a systematic review with meta-analyses and trial sequential analysis of randomized controlled trials. Int J Nurs Stud. 2017 May;70:27-37. doi: 10.1016/j.ijnurstu.2017.02.014. Epub 2017 Feb 14.
- Individual participant dataSharing planned: No. The data sharing plans for the current study are unknown and will be made available at a later date.
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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.
Aysegül İŞLER DALGIÇ, Professor study director
Akdeniz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing manuel acupressure and sea-band acupressure in people with Pediatric Cancer and Nausea With Vomiting Chemotherapy-Induced, run by Akdeniz 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 3 inclusion and 3 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 3 Mar 2021. 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?
number and severity of nausea, number and severity of vomiting (time frame: during study). 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 NCT04651608, which also lists 3 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 3 Mar 2021.