Effect of Family Member's Massage Therapy on the Vital Si... | NCT01909882

Studies
Effect of Family Member's Massage Therapy on the Vital Signs and Glasgow Coma Scale Score

NCT01909882

Sponsor

Baqiyatallah Medical Sciences University

Status

Completed

Last Update Posted

Jul 29, 2013Estimated

Enrollment

180Actual

Phase

Not Applicable

Conditions

Trauma

Interventions

Massage therapy

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2007

Primary Completion Date

Dec 2007Actual

Completion Date

May 2013Actual

First Submitted Date

Jul 22, 2013

First Submission Date that Met QC Criteria

Jul 25, 2013

First Posted Date

Jul 29, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 25, 2013

Last Update Posted Date

Jul 29, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Amir Vahedian-Azimi, Dr, Baqiyatallah Medical Sciences UniversityPrincipal Investigator

Lead Sponsor

Baqiyatallah Medical Sciences UniversityOTHER

Collaborators

Name	Class
Tehran University of Medical Sciences	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Aims and objectives: To determine the effects of family member's massage therapy on the Vital signs and Glasgow Coma Scale Score of hospitalized patients in Intensive Care Unit.

Background: Unalleviated complications related to hospitalization including stress, anxiety, pain, and fear can easily impacts on different systems including brain and stimulates sympatric nerves and as a result causes instabilities in vital signs and deterioration in consciousness level. Alternative and complementary therapies including therapeutic massage have been used to decrease the mentioned side effects.

Design: A Triple-blinded Randomized controlled Clinical Trial Methods: All prolonged hospitalized patients and their families (45 patients and 45 family members in each group) were selected consecutively among the patients admitted in ICU. Data collection tool consisted of two parts. The first part included demographic data (age, mar¬ital status and Body Max Index) and the second part included a checklist to record the patient's vital signs (systolic blood pressure, diastolic blood pressure, respiratory rate, and pulse rate). All measurements were conducted in same time in both groups as follow: before the intervention (the whole massage therapy), one hour, two hours, three hours, and four hours. Collected data was analyzed using descriptive and analytical statistics utilizing SPSS 11.5 software.

Keywords: Family member's massage therapy; Vital signs; Glasgow coma scale; Intensive care unit; Randomized controlled Clinical Trial; Iran.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

180Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Family member's massage therapy	Other	Family member's massage therapy	Other: Massage therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Massage therapy	Other	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Systolic Blood Pressure	Change in Systolic Blood Pressure	1 year

Secondary Outcomes

Measure	Description	Time Frame
Diastolic Blood Pressure	change in diastolic blood pressure	1 year
Respiratory Rate	change in respiratory rate	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Any factors which violate inclusion criteria

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
amir vahedian-azimi, professor	BMSU	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shariati hospital		Tehran	Tehran Province	1956837173	Iran

Condition Browse Module

MeSH Terms

ID	Term
D014947	Wounds and Injuries

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008405	Massage

Ancestor Terms

ID	Term
D064746	Therapy, Soft Tissue
D026201	Musculoskeletal Manipulations
D000529	Complementary Therapies
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided