Condition category
Signs and Symptoms
Date applied
22/11/2016
Date assigned
22/11/2016
Last edited
23/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Cancer patients often suffer from emotional distress such as anxiety or depression. The presence of these symptoms in combination with the physical symptoms of cancer, such as pain and nausea (feeling sick), can have a negative effect on overall quality of life. Progressive muscle relaxation is a technique which involves relaxing muscles through a two-step process: Tensing specific muscle groups followed by releasing the tension and noticing the feeling when relaxing the muscles. This exercise can be an effective way to lower overall tension and stress levels, and help people to relax when they are feeling anxious. The aim of this study is to find out whether this muscle relaxation technique can help reduce levels of anxiety and pain in cancer patients, leading to an improved quality of life.

Who can participate?
Adult cancer patients experiencing anxiety, muscle tension, sleeping difficulties, sadness, or anxiety attacks

What does the study involve?
Participants attend a single session where they learn the muscle relaxation technique. The session takes place in a comfortable room with a trained instructor, either individually or in groups. After the session, participants are encouraged to perform the technique at home at least once a day for the duration of the study. At the start of the study and then every week for a month, participants complete a number of questionnaires to assess their anxiety, pain and nausea levels. In addition, they are asked about their medication use at the same times.

What are the possible benefits and risks of participating?
There are no direct benefits or risks involved with participating in this study.

Where is the study run from?
Hospital Universitario Marques de Valdecilla and nine other hospitals in Spain.

When is the study starting and how long is it expected to run for?
February 2014 to May 2016

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Dr Paula Parás-Bravo

Trial website

Contact information

Type

Scientific

Primary contact

Dr Paula Parás-Bravo

ORCID ID

Contact details

Universidad de Cantabria
Escuela de Enfermeria
Avenida de Valdecilla s/n
santander
39008
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Proyecto tesis

Study information

Scientific title

Is the muscle relaxation technique capable of improving the quality of life of cancer patients with anxiety and pain?

Acronym

Study hypothesis

The progressive muscle relaxation technique in its abbreviated version reduces symptoms of anxiety and pain in cancer patients, leading to improved quality of life.

Ethics approval

1. Ethical Committee of Cantabria, 29/05/2014, ref: 2014.097
2. Alcorcon Hospital Ethics Committee, 03/11/2014
3. Ethical Committee Fuenlabrada Hospital, 03/12/2014
4. Ethical Committee Getafe Hospital, 26/06/2014, ref: A13-14
5. Ethical Committee Puerta Del Hierro Hospital, 27/07/2014, ref: Huph Pi92/14
6. Ethical Committee Instituto Catalan Oncologia Badalona,14/11/2014, ref: Jacobson 01/2014
7. Ethical Committee Instituto Catalan Oncologia Hospitalet, 10/09/2014, ref: Acta 15-14
8. Ethics Committee Salamanca Hospital, 18/07/2014
9. Sierrallama Hospital Ethics Committee, 01/08/2014, ref: 2014.097
10. Committee Etica Complex Hospitalario Navarra, 01/02/2015, ref: Pyto 2015/14

Study design

Non-randomised study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

No participant information sheet available

Condition

Anxiety, pain and nausea in cancer patients

Intervention

All participants receive a guided session in order to learn abbreviated progressive muscle relaxation training by following Bernstein and Borkovec. These sessions are conducted individually or in groups, according to the patients’ condition. All researchers who perform the intervention are fully trained regarding the selection criteria, information provided to participants, data collection procedures and application of the technique in order to unify criteria and reduce possible inter-examiner bias. All researchers receive a written guidance document for the relaxation session. The patients perform the technique in a sitting position in rooms furnished with armchairs, cushions, pleasant lighting and an overall quiet environment. Each session last approximately 60 minutes and is divided into the following 4 parts:
1. An explanation regarding the characteristics of the abbreviated progressive muscle relaxation training by Bernstein and Borkovec
2. Application of a relaxation session
3. Answering possible questions
4. Data collection using the self-administered FACT-G questionnaire and the data collection notebook.

At the end of the session, patients are provided with information regarding the intervention consisting of a brief description of the session, based on text and images, in order to support the performance of this technique at their respective homes. Participants are advised to perform the technique at home at least once a day for the duration of the study.

Participants are followed up weekly for one month.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. Quality of life is measured using the FACT-G (Functional Assessment of Cancer Therapy - General) questionnaire at baseline and weekly for four weeks (1 month)
2. Anxiety is measured using a visual analogue scale (VAS) at baseline and weekly for four weeks (1 month)
3. Pain is measured using a visual analogue scale (VAS) at baseline and weekly for four weeks (1 month)
4. Nausea is measured by asking participants a yes/no question about their nausea levels at baseline and weekly for four weeks (1 month)

Secondary outcome measures

1. Analgesic use is measured through patient interviews at baseline and weekly for four weeks (1 month)
2. Anxiolytic use is measured through patient interviews at baseline and weekly for four weeks (1 month)
3. Hypnotics use is measured through patient interviews at baseline and weekly for four weeks (1 month)
4. Antidepressant use is measured through patient interviews at baseline and weekly for four weeks (1 month)

Overall trial start date

01/02/2014

Overall trial end date

01/05/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 18 years and over
2. Cancer patients
3. Experiencing anxiety, muscle tension, sleeping difficulties, sadness, or anxiety attacks
4. Provision of consent to participate

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

272

Participant exclusion criteria

Patients suffering from hallucinations, delirium or other psychotic symptoms.

Recruitment start date

01/11/2014

Recruitment end date

01/10/2015

Locations

Countries of recruitment

Spain

Trial participating centre

Hospital Universitario Marques de Valdecilla
Av. Valdecilla, 25
Santander
39008
Spain

Trial participating centre

Hospital Fundación Alcorcon
Calle Budapest, 1
Madrid
28922
Spain

Trial participating centre

Hospital Universitario Fuenlabrada
Calle Camino del Molino, 2 Fuenlabrada
Madrid
28942
Spain

Trial participating centre

Hospital Universitario de Getafe
Carr. Madrid - Toledo, Km 12,500
Madrid
28905
Spain

Trial participating centre

Complejo Hospitalario Palmplona
Calle de Irunlarrea, 3 Palmplona
Navarra
31008
Spain

Trial participating centre

Hospital Sierrallana
Barrio de Ganzo, s/n
Cantabria
39300
Spain

Trial participating centre

Hospital Universitario de Salamanca
Paseo de San Vicente, 88-182
Castilla y Leon
37007
Spain

Trial participating centre

Instituto Catalan de Oncologia, Hospitalet
Hospital Duran i Reynals Avinguda de la Granvia, 199-203
Barcelona
08908
Spain

Trial participating centre

Instituto Catalan de Oncologia, Badalona
Hospital Duran i Reynals Avinguda de la Granvia, 199-203
Barcelona
08908
Spain

Trial participating centre

Hospital Universitario Puerta del Hierro
Calle Manuel de Falla, 1
Madrid
28222
Spain

Sponsor information

Organisation

Universidad de Cantabria

Sponsor details

av. Valdecilla sn
Santander
39008
Spain

Sponsor type

University/education

Website

Funders

Funder type

Not defined

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal

Intention to publish date

31/12/2017

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes