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NCT Number: NCT01909882

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

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

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Key information

Conditions

Trauma Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shariati hospital

Tehran, Tehran Province, 1956837173, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Systolic Blood Pressure

    Time frame: 1 year

    Change in Systolic Blood Pressure

Secondary outcomes

  1. Diastolic Blood Pressure

    Time frame: 1 year

    change in diastolic blood pressure

  2. Respiratory Rate

    Time frame: 1 year

    change in respiratory rate

  3. Pulse Rate

    Time frame: 1 year

    change in pulse rate

  4. Glasgow Coma Scale

    Time frame: 1 year

    change in Glasgow Coma Scale

Sponsors and collaborators

Lead sponsor

Baqiyatallah Medical Sciences University

Other

Collaborators

  • Tehran University of Medical Sciences

Registry information

Official study title

The Effect of Family Members' Massage Therapy on Vital Signs and Glasgow Coma Scale Score of Patients Hospitalized in Intensive Care Unit: A Triple-blinded Randomized Controlled Clinical Trial Study

Important dates

Study start
2007
Primary completion
2007
Study completion
2013
First posted
Jul 29, 2013
Registry last updated
Jul 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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