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
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
Scientific
Universidad de Cantabria
Escuela de Enfermeria
Avenida de Valdecilla s/n
santander
39008
Spain
Study information
| Study design | Non-randomised study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | No participant information sheet available |
| Scientific title | Is the muscle relaxation technique capable of improving the quality of life of cancer patients with anxiety and pain? |
| Study objectives | 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(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) studied | 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 |
| Primary outcome measure | 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 study start date | 01/02/2014 |
| Completion date | 01/05/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 272 |
| Key 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 |
| Key exclusion criteria | Patients suffering from hallucinations, delirium or other psychotic symptoms. |
| Date of first enrolment | 01/11/2014 |
| Date of final enrolment | 01/10/2015 |
Locations
Countries of recruitment
- Spain
Study participating centres
Santander
39008
Spain
Madrid
28922
Spain
Fuenlabrada
Madrid
28942
Spain
Madrid
28905
Spain
Palmplona
Navarra
31008
Spain
Cantabria
39300
Spain
Castilla y Leon
37007
Spain
Avinguda de la Granvia, 199-203
Barcelona
08908
Spain
Avinguda de la Granvia, 199-203
Barcelona
08908
Spain
Madrid
28222
Spain
Sponsor information
University/education
av. Valdecilla sn
Santander
39008
Spain
"ROR" |
https://ror.org/046ffzj20 |
|---|
Funders
Funder type
Not defined
No information available
Results and Publications
| Intention to publish date | 31/12/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Planned 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.
