Progressive muscle relaxation technique in the care of anxiety and pain in the cancer patient

ISRCTN ISRCTN81335752
DOI https://doi.org/10.1186/ISRCTN81335752
Secondary identifying numbers Proyecto tesis
Submission date
22/11/2016
Registration date
22/11/2016
Last edited
04/05/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Paula Parás-Bravo
Scientific

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

Study information

Study designNon-randomised study
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Hospital
Study typeQuality of life
Participant information sheet No participant information sheet available
Scientific titleIs the muscle relaxation technique capable of improving the quality of life of cancer patients with anxiety and pain?
Study objectivesThe 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(s)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
Health condition(s) or problem(s) studiedAnxiety, pain and nausea in cancer patients
InterventionAll 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 typeBehavioural
Primary outcome measure1. 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 measures1. 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 study start date01/02/2014
Completion date01/05/2016

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants272
Key inclusion criteria1. 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
Key exclusion criteriaPatients suffering from hallucinations, delirium or other psychotic symptoms.
Date of first enrolment01/11/2014
Date of final enrolment01/10/2015

Locations

Countries of recruitment

  • Spain

Study participating centres

Hospital Universitario Marques de Valdecilla
Av. Valdecilla, 25
Santander
39008
Spain
Hospital Fundación Alcorcon
Calle Budapest, 1
Madrid
28922
Spain
Hospital Universitario Fuenlabrada
Calle Camino del Molino, 2
Fuenlabrada
Madrid
28942
Spain
Hospital Universitario de Getafe
Carr. Madrid - Toledo, Km 12,500
Madrid
28905
Spain
Complejo Hospitalario Palmplona
Calle de Irunlarrea, 3
Palmplona
Navarra
31008
Spain
Hospital Sierrallana
Barrio de Ganzo, s/n
Cantabria
39300
Spain
Hospital Universitario de Salamanca
Paseo de San Vicente, 88-182
Castilla y Leon
37007
Spain
Instituto Catalan de Oncologia, Hospitalet
Hospital Duran i Reynals
Avinguda de la Granvia, 199-203
Barcelona
08908
Spain
Instituto Catalan de Oncologia, Badalona
Hospital Duran i Reynals
Avinguda de la Granvia, 199-203
Barcelona
08908
Spain
Hospital Universitario Puerta del Hierro
Calle Manuel de Falla, 1
Madrid
28222
Spain

Sponsor information

Universidad de Cantabria
University/education

av. Valdecilla sn
Santander
39008
Spain

ROR logo "ROR" https://ror.org/046ffzj20

Funders

Funder type

Not defined

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date31/12/2017
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planPlanned publication in a high-impact peer reviewed journal
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 02/05/2018 Yes No

Editorial Notes

04/05/2018: Publication reference added.