Condition category
Cancer
Date applied
18/12/2012
Date assigned
10/01/2013
Last edited
10/01/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Luís Batalha

ORCID ID

Contact details

Escola Superior de Enfermagem de Coimbra
Av. Bissaya Barreto – Ap. 7001
Coimbra
3046-851
Portugal
+351 239 487 200
batalha@esenfc.pt

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The massage in children with cancer: Effectiveness of a protocol – a randomized controlled trial

Acronym

Study hypothesis

The 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

Ethics Committee for Health IPO-Porto (Comissão de Ética para a Saúde IPO-Porto), Portugal, 30/09/2010, ref: 258/010

Study design

Single-center randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Relief of pain in children with cancer through massage

Intervention

Children 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 type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The 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 measures

Pain 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 trial start date

01/11/2010

Overall trial end date

30/03/2011

Reason abandoned

Eligibility

Participant inclusion criteria

Children between 10 and 18 years old hospitalized in a pediatric department with a diagnostic with cancer and treatment (chemotherapy, antibiotics or steroids)

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Total participants 52 children. Intervention and control group consisting of 26 children each.

Participant exclusion criteria

1. 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

Recruitment start date

01/11/2010

Recruitment end date

30/03/2011

Locations

Countries of recruitment

Portugal

Trial participating centre

Escola Superior de Enfermagem de Coimbra
Coimbra
3046-851
Portugal

Sponsor information

Organisation

Nursing School of Coimbra (Escola Superior de Enfermagem de Coimbra) (Portugal)

Sponsor details

Av. Bissaya Barreto – Ap. 7001
Coimbra
3046-851
Portugal
+351 239 802 850
esenfc@esenfc.pt

Sponsor type

University/education

Website

http://www.esenfc.pt

Funders

Funder type

Research organisation

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes