Dataset Information

A novel clinical-trial design for the study of massage therapy.

ABSTRACT:

Objectives

To develop and test the feasibility and acceptability of a structured design for a massage therapy clinical trial that included a treatment arm designed to control for the non-specific effects of a massage therapy intervention.

Design

Pilot randomized controlled clinical trial.

Setting

University-integrated medicine research clinic.

Interventions

Participants were randomized to a structured Swedish-style massage therapy intervention, a light-touch bodywork control intervention, or usual medical care. Details of the interventions are provided.

Main outcome measures

The primary outcome measures were the adherence of the participants to the study protocol and the perception of the intervention experience.

Results

Forty-four participants were randomized. Participants often found adherence to the twice-weekly outpatient bodywork interventions to be somewhat difficult; while, overall, 84% of participants completed the study, only 76% of those in an intervention arm successfully completed the trial. Participants randomized to the massage arm expressed uniformly positive attitudes both before and after the intervention. While some participants randomized to the light-touch bodywork arm initially expressed some reservations about their randomization assignment, all participants available for interview were pleased with their experience after the intervention period.

Conclusions

The proposed design was found to be relatively straightforward to implement and acceptable to participants. Early disappointment with not receiving massage therapy expressed by the light-touch intervention participants dissipated quickly. Twice-weekly outpatient intervention appointments were found to be highly burdensome for many patients actively undergoing chemotherapy, thus reducing adherence.

SUBMITTER: Patterson M

PROVIDER: S-EPMC2435386 | biostudies-literature | 2008 Jun

REPOSITORIES: biostudies-literature

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Publications

A novel clinical-trial design for the study of massage therapy.

Patterson Michael M Maurer Stephanie S Adler Shelley R SR Avins Andrew L AL

Complementary therapies in medicine 20070921 3

<h4>Objectives</h4>To develop and test the feasibility and acceptability of a structured design for a massage therapy clinical trial that included a treatment arm designed to control for the non-specific effects of a massage therapy intervention.<h4>Design</h4>Pilot randomized controlled clinical trial.<h4>Setting</h4>University-integrated medicine research clinic.<h4>Interventions</h4>Participants were randomized to a structured Swedish-style massage therapy intervention, a light-touch bodywork ...[more]

PMID: 18534330

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Project description:BackgroundUnalleviated complications related to hospitalization, including stress, anxiety, and pain, can easily influence different structures, like the neural system, by enhancing the stimulation of sympathetic nervous pathways and causing unstable vital signs and deterioration in the level of consciousness.ObjectivesThe purpose of this study was to determine the effects of massage therapy by family members on vital signs and Glasgow Coma Scale Score (GCS) of patients hospitalized in the Intensive Care Unit (ICU).Patients and methodsThis randomized controlled clinical trial was conducted at the ICU of the Shariati Hospital during 2012; 45 ICU patients and 45 family members in the experimental group and the same number of patients and family members in the control group were consecutively selected . The data collection instrument consisted of two parts. The first part included demographic data (age, marital status and Body Mass Index) and the second part included a checklist to record the patient's vital signs (systolic blood pressure (SBP), diastolic blood pressure (DBP), respiratory rate (RR), pulse rate (PR)) and GCS. All measurements were done at the same time in both groups before the intervention (full body massage therapy), and 1 hour, 2 hours, 3 hours, and 4 hours after intervention. The patients were provided with a 60-minute full body massage The massage protocol included static, surface tension, stretching, superficial lymph unload, transverse friction, and myofacial releasing techniques.ResultsSignificant differences were observed between experimental and control groups in the SBP at 1 hour, SBP 2 hours, and SBP 3 hours, and also in GCS at 1 hour to GCS at 4 hours (P < 0.05). Multivariate analysis revealed a significant difference between experimental and control groups in SBP at all time points (P < 0.05).ConclusionsMassage via family members had several positive effects on the patients' clinical conditions, and therefore, it should be recognized as one of the most important clinical considerations in hospitalized patients.

Project description:We elicited patient experiences from clinical trial simulations to aid in future trial development and to improve patient recruitment and retention.Two simulations of draft Phase II and Phase III anifrolumab studies for systemic lupus erythematosus (SLE)/lupus nephritis (LN) were performed involving African-American patients from Grady Hospital, an indigent care hospital in Atlanta, GA, USA, and white patients from Altoona Arthritis and Osteoporosis Center in Altoona, PA, USA. The clinical trial simulation included an informed consent procedure, a mock screening visit, a mock dosing visit, and a debriefing period for patients and staff. Patients and staff were interviewed to obtain sentiments and perceptions related to the simulated visits.The Atlanta study involved 6 African-American patients (5 female) aged 27-60 years with moderate to severe SLE/LN. The Altoona study involved 12 white females aged 32-75 years with mild to moderate SLE/LN. Patient experiences had an impact on four patient-centric care domains: 1) information, communication, and education; 2) responsiveness to needs; 3) access to care; and 4) coordination of care; and continuity and transition. Patients in both studies desired background material, knowledgeable staff, family and friend support, personal results, comfortable settings, shorter wait times, and greater scheduling flexibility. Compared with the Altoona study patients, Atlanta study patients reported greater preferences for information from the Internet, need for strong community and online support, difficulties in discussing SLE, emphasis on transportation and child care help during the visits, and concerns related to financial matters; and they placed greater importance on time commitment, understanding of potential personal benefit, trust, and confidentiality of patient data as factors for participation. Using these results, we present recommendations to improve study procedures to increase retention, recruitment, and compliance for clinical trials.Insights from these two studies can be applied to the development and implementation of future clinical trials to improve patient recruitment, retention, compliance, and advocacy.

Dataset Information

A novel clinical-trial design for the study of massage therapy.

Objectives

Design

Setting

Interventions

Main outcome measures

Results

Conclusions

Publications

A novel clinical-trial design for the study of massage therapy.

Similar Datasets

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