NCT01909882

Brief Summary

The effect of family member's massage therapy on the Vital signs and Glasgow Coma Scale Score of hospitalized patients in Intensive Care Unit: A Triple-blinded Randomized controlled Clinical Trial Study

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
5.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 29, 2013

Completed
Last Updated

July 29, 2013

Status Verified

August 1, 2012

Enrollment Period

4 months

First QC Date

July 22, 2013

Last Update Submit

July 25, 2013

Conditions

Keywords

Family member's massage therapyVital signsGlasgow coma scaleIntensive care unitRandomized controlled Clinical TrialIran

Outcome Measures

Primary Outcomes (1)

  • Systolic Blood Pressure

    Change in Systolic Blood Pressure

    1 year

Secondary Outcomes (4)

  • Diastolic Blood Pressure

    1 year

  • Respiratory Rate

    1 year

  • Pulse Rate

    1 year

  • Glasgow Coma Scale

    1 year

Study Arms (1)

Family member's massage therapy

OTHER

Family member's massage therapy

Other: Massage therapy

Interventions

One session of massage therapy (for 60 minutes) was done by the patient's family member. Almond oil was used for effleurage and massage facilitation. Back, shoulder deltoid muscles, front and posterior parts of legs, arms, forearms, front and back parts of thighs, palms and fingers, metatarsus, front and back of feet and toes, belly and chest, auxiliaries and neck muscles of the patients were massaged. Massage techniques used included static massage, surface tension techniques, stretching massage, superficial lymph unload, transverse friction techniques, and myofacial releasing techniques. All the massage sessions were conducted in the morning shifts. For the control group, there was no intervention and patients just received the routine care of the unit.

Family member's massage therapy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • more than 10-day hospitalization, hemodynamic stability, having the Glasgow coma scale score between 7 to 12, intra cranial pressure less than 20 mmHg, no limitation or contraindication for changing in body position (including active bleeding or flail chest) and body massage (such as advanced burn degrees, severe dyspnea, fever, etc) and willing to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shariati hospital

Tehran, Tehran Province, 1956837173, Iran

Location

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Massage

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • amir vahedian-azimi, professor

    BMSU

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

July 22, 2013

First Posted

July 29, 2013

Study Start

August 1, 2007

Primary Completion

December 1, 2007

Study Completion

May 1, 2013

Last Updated

July 29, 2013

Record last verified: 2012-08

Locations