Acupressure in Reducing Post-TBI Fatigue

NCT ID: NCT04429126

Last Updated: 2022-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2021-12-31

Brief Summary

Fatigue is a common symptom experienced by patients with traumatic brain injury (TBI). Prior works have demonstrated that it may profoundly impact the ability to return to productive activity and cognitive functions. However, few interventions have been applied in this population.The purpose of the current will be to test the effect of acupressure on fatigue reduction after traumatic brain injury.

Detailed Description

Fatigue is a pervasive and critical long-lasting symptom experienced by patients with traumatic brain injury (TBI) and can persist up to months or years after head injury. However, thus far, only few non-pharmacological interventions, such as mindfulness, are implemented in reducing fatigue in TBI survivors. Prior works have suggested that acupressure can significantly improve fatigue in different populations, such as cancers survivors and patients with hemodialysis. Therefore, we would like to test whether acupressure effectively improve fatigue after TBI.

Conditions

Fatigue

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

4-point acupressure group

The 5-point acupressure group will be instructed on the following acupressure points: sanyinjiao (SP6), Zu San Li (ST36), shenmen (TF4), Yongquan (KI-1), and He Gu (LI4).

Bilateral 1.5 min for each point, three times daily for 4 weeks.

Group Type: EXPERIMENTAL

Acupressure

Intervention Type: BEHAVIORAL

Two types acupressure interventions, 5-point and 2-point acupressure groups, will be conducted in the current study.

4 -point acupressure group

The 2-point acupressure group will be instructed on the following acupressure points: He Gu (LI4) and Tai Chong (LV3).

Bilateral 1.5 min for each point, three times daily for 4 weeks.

Group Type: ACTIVE_COMPARATOR

Acupressure

Intervention Type: BEHAVIORAL

Two types acupressure interventions, 5-point and 2-point acupressure groups, will be conducted in the current study.

Usual care

The usual care group will be required to maintain their daily activities. Weekly telephone follow-up will be conducted by principle investigator.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Acupressure

Two types acupressure interventions, 5-point and 2-point acupressure groups, will be conducted in the current study.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Diagnosed with traumatic brain injury over 6 months with initial GCS (admitted GCS) from 3-12.
• Aged between 20-65 years
• Are able to communicate in Chinese and Mandarin
• Are able to complete the questionnaires
• Complain of tiredness and cannot be restored even after a rest.
• No physical disability and visual impairment

Exclusion Criteria

• With skin lesion
• had diagnosis of neuropathy and paraesthesia prior to study.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Hsiao-Yean Chiu

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hsiao-Yean Chiu, PhD

Role: PRINCIPAL_INVESTIGATOR

School of Nursing, Taipei Medical University

Locations

Hsiao-Yean Chiu

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

109059-E

Identifier Type: -

Identifier Source: org_study_id