A Relaxation Technique enhances Psychological well-being and cellular Immune Competence of elderly people in a nursing home

ISRCTN ISRCTN85410212
DOI https://doi.org/10.1186/ISRCTN85410212
Secondary identifying numbers N/A
Submission date
13/06/2013
Registration date
27/06/2013
Last edited
28/10/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Abilio Reig-Ferrer
Scientific

Carretera San Vicente del Raspeig
Alicante
03690
Spain

Study information

Study designRandomized controlled study; Psychological intervention
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA relaxation technique enhances psychological well-being and cellular immune competence of elderly people in a nursing home: a randomized controlled study
Study acronymRTPIC
Study objectivesThe 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(s)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
Health condition(s) or problem(s) studiedElderly, relaxation technique, immune competence, psychological well-being
Intervention1. 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 typeOther
Primary outcome measurePsychological, 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 measuresAt 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 study start date03/10/2011
Completion date24/09/2012

Eligibility

Participant type(s)Patient
Age groupSenior
SexBoth
Target number of participantsSample size: 30
Key inclusion criteria1. 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
Key exclusion criteriaParticipants with indications of cognitive impairment
Date of first enrolment03/10/2011
Date of final enrolment24/09/2012

Locations

Countries of recruitment

  • Spain

Study participating centre

Carretera San Vicente del Raspeig
Alicante
03690
Spain

Sponsor information

University of Alicante (Spain)
University/education

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

Website http://www.ua.es
ROR logo "ROR" https://ror.org/05t8bcz72

Funders

Funder type

University/education

Department of Health Psychology, University of Alicante (Spain)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 23/08/2014 Yes No