The massage in children with cancer: Effectiveness of a protocol

ISRCTN ISRCTN43067816
DOI https://doi.org/10.1186/ISRCTN43067816
Secondary identifying numbers N/A
Submission date
18/12/2012
Registration date
10/01/2013
Last edited
10/01/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Pain is an unpleasant and subjective experience that has sensorial, affective, cognitive, social and behavioral components. It is a major cause of human suffering and loss of quality of life. Health professionals have an ethical responsibility and a key role to play in order to provide effective pain control.
Unconventional therapies exist but there is little evidence about well they work. This is the case for children with cancer. The aim of this study is to evaluate how well three massage sessions will work in reducing pain in children with cancer aged between 10 and 18 years old.

Who can participate?
Children diagnosed with cancer and undergoing treatment (chemotherapy, antibiotics, or steroids). It excluded children not diagnosed, in terminal phase, in the first three days after surgery, in isolation from contact, with fever, bleeding risk and altered states of consciousness or cognitive disturbances.

What does the study involve?
Participants were randomly allocated to a treatment group or a control group.
In the treatment group, the treatment consisted in three massage sessions on alternate days during a week (day 1, 3 and 5). The massage technique included gliding movements, light compression and the use of heated sweet almond oil. Each session lasted between 20 and 30 minutes. The control group received usual care. All children received the same care, except the application of massage in the treatment group.

What are the possible benefits and risks of participating?
Study participants could benefit from better pain control and less interference of pain in their daily lives. There are no risks as long as the exclusion criteria are followed.
The study was conducted according to the Declaration of Helsinki of the World Medical Association. Written consent was provided by the child and the child's legal guardians.

Where is the study run from?
This study involved the Nursing School of Coimbra and Portuguese Oncology Institute of Porto (Portugal).

When is the study starting and how long is it expected to run for?
The study took place at the Portuguese Oncology Institute of Porto between November 2010 and March 2011.

Who is funding the study?
Portuguese Oncology Institute of Porto (Portugal)

Who is the main contact?
Professor Luís Batalha
batalha@esenfc.pt

Contact information

Prof Luís Batalha
Scientific

Escola Superior de Enfermagem de Coimbra
Av. Bissaya Barreto – Ap. 7001
Coimbra
3046-851
Portugal

Phone +351 239 487 200
Email batalha@esenfc.pt

Study information

Study designSingle-center randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleThe massage in children with cancer: Effectiveness of a protocol – a randomized controlled trial
Study objectivesThe implementation of a protocol of three massage sessions on alternative days during a week reduces the pain and its interference in the activities of children (10 to 18 years), hospitalized with cancer.
Ethics approval(s)Ethics Committee for Health IPO-Porto (Comissão de Ética para a Saúde IPO-Porto), Portugal, 30/09/2010, ref: 258/010
Health condition(s) or problem(s) studiedRelief of pain in children with cancer through massage
InterventionChildren and adolescents hospitalized in a pediatric oncology department aged 10 to 18 years with a diagnostic disease and treatment (chemotherapy, antibiotics or steroids) were randomly divided into two groups (control and intervention).

The children in the intervention group (GI) were subjected to a protocol consisting of three massage sessions in alternative days, during a week (day 1, 3 and 5). The massage technique consisted of gliding movements, light compression and the use of heated sweet almond oil. Each session lasted between twenty and thirty minutes.

Control group (CG) received usual care.

Finally, the efficacy of the protocol was measured by analyzing the differences between the results at the beginning (day 0) and the results at the end of protocol (day 6) by evaluating the pain and their interference in the activities of children.
Intervention typeOther
Primary outcome measureThe pain is measured by using the Visual Analogue Scale (VAS), scored (0 = no pain, 10 = unbearable pain) and physical functioning, assessed by the Brief Pain Inventory scales (BPI), scored numerical rating scale (0 = without interferences in the activity, 10 = the maxim interference) at the beginning (day 0) and at the end of protocol (day 6).
Secondary outcome measuresPain intensity by the Visual Analogue Scale (VAS) scored (0 = no pain, 10 = unbearable pain) was assessed in a break of half-hour at the beginning and the end of each session massage.
Overall study start date01/11/2010
Completion date30/03/2011

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit10 Years
Upper age limit18 Years
SexBoth
Target number of participantsTotal participants 52 children. Intervention and control group consisting of 26 children each.
Key inclusion criteriaChildren between 10 and 18 years old hospitalized in a pediatric department with a diagnostic with cancer and treatment (chemotherapy, antibiotics or steroids)
Key exclusion criteria1. Children in terminal phase
2. The first three days after surgery
3. In isolation from contact with fever
4. Bleeding risk (platelet count less than 10 000)
5. Altered states of consciousness or cognitive disorders
Date of first enrolment01/11/2010
Date of final enrolment30/03/2011

Locations

Countries of recruitment

  • Portugal

Study participating centre

Escola Superior de Enfermagem de Coimbra
Coimbra
3046-851
Portugal

Sponsor information

Nursing School of Coimbra (Escola Superior de Enfermagem de Coimbra) (Portugal)
University/education

Av. Bissaya Barreto – Ap. 7001
Coimbra
3046-851
Portugal

Phone +351 239 802 850
Email esenfc@esenfc.pt
Website http://www.esenfc.pt
ROR logo "ROR" https://ror.org/03c3y8w73

Funders

Funder type

Research organisation

Portuguese Oncology Institute of Porto [Instituto Português de Oncologia do Porto, Francisco Gentil, EPE (IPOPFG, E.P.E.)] (Portugal)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan