Affective Touching on Poststroke Depression
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|ClinicalTrials.gov Identifier: NCT03789994|
Recruitment Status : Not yet recruiting
First Posted : December 31, 2018
Last Update Posted : January 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Post-stroke Depression||Behavioral: Affective touch Other: Fine motor exercise||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||184 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Health Services Research|
|Official Title:||Family Caregivers Affective Touching for Improving Depressive Symptoms of Community Dwelling Stroke Survivors Through Security Priming|
|Estimated Study Start Date :||January 15, 2019|
|Estimated Primary Completion Date :||December 30, 2021|
|Estimated Study Completion Date :||December 31, 2021|
Experimental: Affective touch group
Survivors in the intervention group will receive a total of 36 sessions of a 15-minute affective touch intervention performed by their family caregivers in their homes. Sessions will be scheduled for every alternate weekday (three times a week) for 12 weeks. A trained research nurse (RN) will conduct three 30-minute caregiver training sessions to support the caregivers in delivering the affective touch.
To put caregivers in a more relaxed mood for delivering the intervention, the RN will work with them to identify a time that they feel less burdensome, and teach them to perform deep breathing for relaxation before the affective touching begins. Also, the survivor-caregiver dyad will be asked to sit in a comfortable position and switch off television or radio during the intervention.
Behavioral: Affective touch
The affective touch comprises of two elements, namely the signal of care, love and acceptance, and stimulation of CT afferent of the skin. Caregivers will be trained to perform light stroking on stroke survivor's forearm while reviewing happy events with the use of photos.
Fine motor group
To address the additional attention given by caregivers during affective touch, the control group will be asked to sit beside the survivors when they go through the fine motor exercises which are commonly used for rehabilitation. Caregivers will be instructed to provide only necessary help in preparing the equipment, and to avoid touching or talking to the survivors during the 15-minute exercise session. Two such sessions will be arranged for survivors to master the skills needed, and for caregivers to practise the required level of interaction during the exercise training. Participants will be instructed to do the exercise three times a week (every alternate weekday) over 12 weeks.
Other: Fine motor exercise
Fine motor exercises that are commonly used for rehabilitation.
- Change of number of depressive symptoms of stroke survivors at 3 months [ Time Frame: Change of baseline number of depressive symptoms at 3 months ]Number of depressive symptoms of stroke survivors will be measured by the Chinese version of the 20-item Centre of Epidemiology Studies Depression Scale, which rates participant's mood on a four-point Likert scale (0 = rarely or none of the time, 3 = almost or all of the time), higher score indicating more severe symptoms.
- Change of number of depressive symptoms of stroke survivors at 6 months [ Time Frame: Change of baseline number of depressive symptoms at 6 months ]Number of depressive symptoms of stroke survivors will be measured by the Chinese version of the 20-item Centre of Epidemiology Studies Depression Scale, which rates participant's mood on a four-point Likert scale (0 = rarely or none of the time, 3 = almost or all of the time), higher score indicating more severe symptoms.
- Change of state of attachment security of stroke survivors at 3 and 6 months [ Time Frame: Baseline, 3 and 6 months ]State of attachment security of stroke survivors will be measured by the Chinese version of State Adult Attachment Measure (SAAM). The SAAM comprises 21 items and participants will be asked to use a seven-point Likert scale (1 = disagree strongly; 7 = agree strongly) to rate the extent to which they agree with the items assessing state of attachment security, state of attachment avoidance, and state of attachment anxiety.
- Change of state self-esteem of stroke survivors at 3 and 6 months [ Time Frame: Baseline, 3 and 6 months ]State self-esteem of stroke survivors will be measured by the Chinese version of the State Self-esteem Scale (SSES). The SSES comprised 20 items and participants will indicate whether each item is true of themselves at that moment, using a five-point Likert scale (1 = not at all, 5 = extremely). Higher scores indicate greater state self-esteem.
- Change of perceived family harmony of stroke survivors at 3 and 6 months [ Time Frame: Baseline, 3 and 6 months ]Perceived family harmony of stroke survivor will be measured by the five-item Chinese version of the Family Harmony Scale (FHS). Participants will indicate whether they agree with the items describing family harmony on a five-point Likert-scale (1 = strongly agree, 5 = strongly disagree), lower scores indicating greater harmony.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03789994
|Contact: Ho Yu CHENG, PhDfirstname.lastname@example.org|
|China, Please Select|
|The Nethersole School of Nursing, Chinese University of Hong Kong||Not yet recruiting|
|Hong Kong SAR, Please Select, China|
|Contact: Ho Yu CHENG, PhD, RN +852 39436230 email@example.com|