Stellate Ganglion Blockade to Reduce Cardiac Anxiety and PTSD Symptoms in Cardiac Arrest Survivors

Horner syndrome is a condition that affects the face and eye on one side of the body, being caused by a disrupted nerve pathway from the brain to the head and neck. This syndrome can be assessed through a visual exam, involving the observation of decreased pupil size, a drooping eyelid and decreased sweating on the affected side of the face.

Time frame: Immediately post-procedure

Population: 11 patients reported elevated PTSD and/or cardiac anxiety scores (an initial eligibility requirement for our study). Of these 11 patients, 10 were prescribed anticoagulants, rendering them ineligible for our study since one of the exclusion criteria is current anticoagulant use. One patient was enrolled and completed all study procedures.

This is designed to measure the rate of enrollment, with \<4 patients/month considered not meeting outcome

Time frame: Assessed at 10 Month from the beginning of enrollment

Population: During the enrollment period, 11 patients reported elevated PTSD and/or cardiac anxiety scores (an initial eligibility requirement for our study). Of these 11 patients, 10 were prescribed anticoagulants, rendering them ineligible for the study since one of the exclusion criteria is current anticoagulant use. One patient was enrolled and completed all study procedures.

This is designed to measure the feasibility of successful enrollment.

Time frame: Baseline (pre-procedure)

Population: During the enrollment period, 11 patients reported elevated PTSD and/or cardiac anxiety scores (an initial eligibility requirement for our study). Of these 11 patients, 10 were prescribed anticoagulants, rendering them ineligible for the study since one of the exclusion criteria is current anticoagulant use. One patient was enrolled and completed all study procedures.

This is designed to assess the long-term attrition and lost to follow-up up to 12 weeks post-enrollment.

Time frame: 12-weeks post-procedure

Population: There were no participants randomized to the Stellate Ganglion Block + Psychoeducation arm

This is designed to assess the short-term attrition and lost to follow-up up to 4 weeks post-enrollment.

Time frame: 4 weeks post-enrollment

Population: There were no participants randomized to the Stellate Ganglion Block + Psychoeducation arm

This is designed to assess the feasibility of administering psychoeducation, with \>80% of the components in the checklist as a threshold for success.

Time frame: Assessed at baseline post-procedure

Population: There were no participants randomized to the Stellate Ganglion Block + Psychoeducation arm

the proportion of participants with \>80% of the total actigraph wear time. It is designed to assess the acceptability of actigraphy

Time frame: Assessed at 4-weeks post-procedure

Population: 11 patients reported elevated PTSD and/or cardiac anxiety scores (an initial eligibility requirement for our study). Of these 11 patients, we learned that a majority (10 out of 11) were prescribed anticoagulants, rendering them ineligible for our study since one of the exclusion criteria is current anticoagulant use. One patient was enrolled and completed all study procedures.

This is a questionnaire that assesses the number of participants with credibility. Through this questionnaire, whether the participant will proceed through the study will be determined.

Time frame: Immediately post-procedure

Population: 11 patients reported elevated PTSD and/or cardiac anxiety scores (an initial eligibility requirement for our study). Of these 11 patients, we learned that a majority (10 out of 11) were prescribed anticoagulants, rendering them ineligible for our study since one of the exclusion criteria is current anticoagulant use. One patient was enrolled and completed all study procedures.

This is a 20-item self-report measure that assesses symptoms of PTSD. Each item can be scored on a scale of 0-4, Not at all (0), A little bit (1), Moderately (2), Quite a bit (3), and Extremely (4) are the eligible responses. There are five clusters that are assessed: items 1-5, items 6-7, items 8-14, and items 15-20. Each of these sub-scores are summed to receive a score between 0-80; a higher score indicating a higher severity of PTSD symptoms. The cutoff score that is indicative of probable PTSD is 31-33.

Time frame: Assessed pre-procedure and then repeated at 4-weeks post-procedure

Population: There were no participants randomized to the Stellate Ganglion Block + Psychoeducation arm

The effect of SGB-PsychoED intervention on cardiac anxiety will be assessed using cardiac anxiety questionnaire (CAQ).This is an 18-item questionnaire that assesses anxiety through three divided sub-scales: fear (items 10, 11, 13-18), avoidance (items 2, 5, 7, 9, 12), and attention (items 1, 3, 4, 6, 8). Each item is scored via the 5-point Likert scale: Never (0), Rarely (1). Sometimes (2), Often (3), and Always (4). Item responses are summed to receive a score between 0-72. Higher reported scores indicate a greater heart-focused anxiety.

Time frame: Assessed pre-procedure and then repeated at 4-weeks post-procedure

Population: 11 patients reported elevated PTSD and/or cardiac anxiety scores (an initial eligibility requirement for our study). Of these 11 patients, we learned that a majority (10 out of 11) were prescribed anticoagulants, rendering them ineligible for our study since one of the exclusion criteria is current anticoagulant use. One patient was enrolled and completed all study procedures.

The effect of SGB-PsychoED intervention on depression will be assessed using the eight-item Patient Health Questionnaire depression scale (PHQ-8). This is an 8-item scale that assesses depression, with responses to each item being: Not at all (0), Several days (1), More than half the days (2), and Nearly every day (3). The sub-scores are summed to result in a score from 0-24. Higher scores indicate higher indication of depression. Scores that are reported as 10 or above are assessed to be showing symptoms of depression.

Time frame: Assessed pre-procedure and then repeated at 4-weeks post-procedure

Population: 11 patients reported elevated PTSD and/or cardiac anxiety scores (an initial eligibility requirement for our study). Of these 11 patients, we learned that a majority (10 out of 11) were prescribed anticoagulants, rendering them ineligible for our study since one of the exclusion criteria is current anticoagulant use. One patient was enrolled and completed all study procedures.

The effect of the intervention on generalized anxiety disorder will be assessed using the generalized anxiety disorder scale-7 (GAD-7). This is a 7-item scale that assesses the presence of generalized anxiety disorder. Responses can be given as Not at all (0), Several days (1), More than half the days (2), and Nearly every day (3). These scores can be summed to produce a score between 0 and 21. Scores between 0-4 indicate minimal anxiety, scores between 5-9 indicate mild anxiety, scores between 10-14 indicate moderate anxiety, and scores greater than 15 indicate severe anxiety.

Time frame: Assessed pre-procedure and then repeated at 4-weeks post-procedure

Population: 11 patients reported elevated PTSD and/or cardiac anxiety scores (an initial eligibility requirement for our study). Of these 11 patients, we learned that a majority (10 out of 11) were prescribed anticoagulants, rendering them ineligible for our study since one of the exclusion criteria is current anticoagulant use. One patient was enrolled and completed all study procedures.

Effect of SGB-PsychoED intervention on mean minutes/day of physical activity as measured by the objective actigraphy data

Time frame: Assessed at 4-weeks post-discharge

Population: 11 patients reported elevated PTSD and/or cardiac anxiety scores (an initial eligibility requirement for our study). Of these 11 patients, we learned that a majority (10 out of 11) were prescribed anticoagulants, rendering them ineligible for our study since one of the exclusion criteria is current anticoagulant use. One patient was enrolled and completed all study procedures.

Effect of SGB-PsychoED intervention on mean hours/day of sleep as measured by the objective actigraphy data

Time frame: Assessed at 4-weeks post-discharge

Population: 11 patients reported elevated PTSD and/or cardiac anxiety scores (an initial eligibility requirement for our study). Of these 11 patients, we learned that a majority (10 out of 11) were prescribed anticoagulants, rendering them ineligible for our study since one of the exclusion criteria is current anticoagulant use. One patient was enrolled and completed all study procedures.