Condition category
Mental and Behavioural Disorders
Date applied
13/06/2013
Date assigned
27/06/2013
Last edited
28/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The aging process involves a decline in immune function that renders elderly people more vulnerable to disease. In residential programs for the aged, it is vital to reduce the risk of disease, to maintain independence, and increase psychological well-being and quality of life. Our goal is to test the effects of a psychological program of geriatric intervention based on the application of a relaxation technique, namely Benson’s relaxation technique, on psychological well-being and immune function in elderly people residing in a nursing home.

Who can participate?
Residents of a nursing home (men and women), over 65 years old, without cognitive impairment; not are taking drugs with significant effects on endocrine or immune function; do not have health problems directly related to immune function; and not have suffered an extremely negative life event within the year prior to study participation.

What does the study involve?
The study involved three stages of assessment and an intervention. It was conducted over two weeks. The participants were randomly allocated to a control group (standard care was given by the physician) and treatment group (relaxation technique). The initial assessment was carried out before the first session of relaxation technique training; the other assessments were repeated, at the end of treatment and three months later. Both groups were evaluated at the same time. Finally, clinical and psychological variables were compared in both groups. The control group received the relaxation technique after last assessment (after follow-up).

What are the possible benefits and risks of participating?
It has shown an immediate benefit for those patients who were part of the treatment group. The technique has proven effective in improving psychological well-being of people who practice it.
Participation in this study involved no risk.

Where is the study run from?
The study was carried out in the nursing home “Residencia de Tercera Edad Alacant (Juan XXIII)”. This study was conducted by a multidisciplinary group of psychologists of the Department of Health Psychology of the University of Alicante, in collaboration with physicians of the University Hospital of San Juan of Alicante and Consellería de Bienestar Social (Generalitat Valenciana).

When is the study starting and how long is it expected to run for?
The study started in October of 2011, and finished in September of 2012.

Who is funding the study?
Department of Health Psychology, University of Alicante.

Who is the main contact?
Professor Dr. Abilio Reig-Ferrer
areig@ua.es

Trial website

Contact information

Type

Scientific

Primary contact

Dr Abilio Reig-Ferrer

ORCID ID

Contact details

Carretera San Vicente del Raspeig
Alicante
03690
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A relaxation technique enhances psychological well-being and cellular immune competence of elderly people in a nursing home: a randomized controlled study

Acronym

RTPIC

Study hypothesis

The aim of this study was to test the effects of a psychological program of geriatric intervention based on the application of a passive relaxation technique known as Benson’s relaxation technique, on psychological well-being and cellular immune competence in elderly people residing in a nursing home. We hypothesized that the Benson’s technique would generate positive effects on clinical and psychological well-being.

Ethics approval

Residencia de Tercera Edad Alacant (Juan XXIII) of the Consellería de Bienestar Social (Generalitat Valenciana), and Faculty of Health Sciences (University of Alicante). Approval date 05/09/2011

Study design

Randomized controlled study; Psychological intervention

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

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

Elderly, relaxation technique, immune competence, psychological well-being

Intervention

1. Control group: standard care was given by the physician. This group was randomized to wait-list condition.
2. Intervention group: Psychological treatment was given by an expert psychologist. It consisted of an empirical training in the “relaxation response” technique designed by Benson which we named the “tranquilization technique”. This relaxation technique consists of engaging in repeated resting periods in which the mind is free from preoccupations and the body is liberated of all tension.

Both groups were assessed before the beginning of the treatment, at the end, and three months later.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Psychological, clinical and immunological measures were collected over the pre-treatment, post-treatment and follow up after the intervention. The following variables were collected:
1. Psychological variables: life satisfaction degree evaluated through the Satisfaction with Life Scale; positive and negative affect assessed with Bradburn’s Affect Balance Scale; quality of life of the participants by means of Nottingham Health Profile; and a Symptom List related with the Benson’s relaxation response.
2. Clinical variables: functional assessment by means of Katz Index of ADL, physical parameters (BMI, blood pressure and heart rate), hematological parameters (red and white blood cells counts, and blood differential, hemoglobin, hematocryte, mean corpuscular volume, platelets, and erythrocyte sedimentation rate) and blood biochemistry measures (Glucose, creatinine, urea, uric acid, total cholesterol, HDL and LDL cholesterol, triglycerids, AST, ALT, GGT, total proteins, and serum albumin).
3. Immunological variables: we recorded the following molecules: CD4, CD8, CD19, CD56, CD71, CD97, CD134, and CD173. At the immune level, our results show significant group differences in various lymphocyte sub populations at the end of treatment.

Secondary outcome measures

At the psychological level, the relaxation technique produced positive effects in that there was a decline in negative affect, degree of psychological distress, and perception of symptomatology with respect to baseline levels at the beginning of the study. Furthermore, the treatment group showed gains in quality of life at the three-month follow-up.

Overall trial start date

03/10/2011

Overall trial end date

24/09/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Participants should not to be taking drugs with significant effects on endocrine or immune function (e.g., corticosteroids or antimetabolites)
2. Participants should not to have health problems directly related to immune function (i.e., endocrine diseases, cancer, arthritis, asthma, or infectious diseases)
3. Participants should not have endured an extremely negative life event within the year prior to study participation

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

Sample size: 30

Participant exclusion criteria

Participants with indications of cognitive impairment

Recruitment start date

03/10/2011

Recruitment end date

24/09/2012

Locations

Countries of recruitment

Spain

Trial participating centre

Carretera San Vicente del Raspeig
Alicante
03690
Spain

Sponsor information

Organisation

University of Alicante (Spain)

Sponsor details

c/o Abilio Reig-Ferrer
Carretera San Vicente del Raspeig s/n
Alicante
03690
Spain

Sponsor type

University/education

Website

http://www.ua.es

Funders

Funder type

University/education

Funder name

Department of Health Psychology, University of Alicante (Spain)

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

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25151398

Publication citations

  1. Results

    Reig-Ferrer A, Ferrer-Cascales R, Santos-Ruiz A, Campos-Ferrer A, Prieto-Seva A, Velasco-Ruiz I, Fernandez-Pascual MD, Albaladejo-Blazquez N, A relaxation technique enhances psychological well-being and immune parameters in elderly people from a nursing home: a randomized controlled study., BMC Complement Altern Med, 2014, 14, 311, doi: 10.1186/1472-6882-14-311.

Additional files

Editorial Notes