Stress Balls for Anxiety During Thyroid Biopsies

Overseen By Cassidy Singh

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nova Scotia Health Authority

Disqualifiers: Previous biopsy, Multiple lesions, Allergy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

300 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Stress Balls for reducing anxiety during thyroid biopsies?

Research on similar treatments, like classical music and meditation, shows they can help reduce anxiety during medical procedures, suggesting that stress balls might also be effective in calming patients during thyroid biopsies. ^{1 2 3 4 5}

Is using a stress ball safe for humans?

Using a stress ball is generally safe for humans, as shown in studies where it was used during medical procedures like endoscopy and PCR tests without any reported safety issues. ^{1 2 6 7 8}

How does using stress balls for anxiety during thyroid biopsies differ from other treatments for anxiety?

Using stress balls for anxiety during thyroid biopsies is unique because it provides a simple, non-drug method to help manage anxiety through physical activity, which can be more immediate and accessible compared to traditional anxiety treatments like medication or therapy. ^{9 10 11 12 13}

What is the purpose of this trial?

Patients undergoing thyroid biopsy under local anesthetic will be asked to fill out a questionnaire that evaluates their anxiety level before and after their procedure. Patients will be randomly assigned to either use an anxiety reducing tool (stress balls in each hand) to take their mind off the procedure or will not receive an anxiety reducing tool.

Research Team

Robert J Abraham, MD, FRCPC

Principal Investigator

Nova Scotia Health Authority/Dalhousie University

Eligibility Criteria

This trial is for adults aged 18 or older who are about to undergo a thyroid biopsy under local anesthetic and can consent to treatment and research. It's designed for those experiencing anxiety related to the procedure.

Inclusion Criteria

I am having a thyroid or prostate biopsy under local anesthetic and can consent to treatment and research.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Procedure

Participants undergo thyroid biopsy with or without the use of stress balls to assess anxiety levels

Approximately 2 hours

1 visit (in-person)

Follow-up

Participants complete post-procedure questionnaires to assess intraprocedural anxiety

Immediate post-procedure

1 visit (in-person)

Data Analysis

Data collected from questionnaires is analyzed to determine the efficacy of stress balls in reducing anxiety

1 year

Treatment Details

Interventions

• Stress Balls

Trial Overview The study is testing whether using stress balls during a thyroid biopsy can help reduce anxiety. Participants will be randomly divided into two groups: one will use stress balls, while the other won't receive any anxiety-reducing tools.

Participant Groups

Group I: Stress Balls Experimental Treatment 1 Intervention

Patients given a stress ball in each hand.

Group II: No Stress Balls Active Control 1 Intervention

Patients NOT given a stress ball in each hand.

Who Is Running the Clinical Trial?

Nova Scotia Health Authority

Lead Sponsor

Trials

302

Recruited

95,300+

Findings from Research

Providing video-based information significantly reduced anxiety levels in patients undergoing thyroid fine-needle aspiration biopsy, as indicated by lower STAI-S scores after the intervention in Group 2, compared to no change in Group 1.

While both groups reported similar pain levels during the biopsy, the video-based information approach was noted as an effective and easy method to help alleviate patient anxiety before the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of an Information Video before Thyroid Biopsy on Patients' Anxiety. Ay, S., Ata, N., Oncu, F.[2022]

In a study of 82 patients undergoing transrectal ultrasound (TRUS) biopsy, those who received stress management techniques, including music therapy and education, reported significantly lower pain levels after the procedure compared to those who only received routine care (P=0.03).

Patients who participated in the stress management program also experienced a greater reduction in anxiety levels post-biopsy, indicating that these techniques can effectively alleviate both anxiety and pain during this medical procedure (P=0.02).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of stress management in patients undergoing transrectal ultrasound-guided biopsy of the prostate. Chiu, LP., Tung, HH., Lin, KC., et al.[2020]

In a study involving 121 women undergoing imaging-guided breast biopsy, guided meditation significantly reduced pain during the procedure compared to music, highlighting its efficacy as a non-pharmacological intervention.

Both guided meditation and music were effective in reducing anxiety and fatigue after the biopsy, while the standard-care control group experienced increased fatigue, suggesting that these interventions can enhance patient comfort during medical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imaging-Guided Core-Needle Breast Biopsy: Impact of Meditation and Music Interventions on Patient Anxiety, Pain, and Fatigue. Soo, MS., Jarosz, JA., Wren, AA., et al.[2022]

Women who received immediate results from fine needle aspiration biopsy (FNAB) experienced a significantly greater reduction in anxiety levels compared to those who had delayed communication, particularly among those with benign results.

The study involved 102 women (51 in each group) and found that while immediate communication helped reduce anxiety for benign results, it did not affect anxiety levels for those with malignant diagnoses, suggesting that timely communication may be beneficial for overall patient experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anxiety in patients with symptomatic breast disease: effects of immediate versus delayed communication of results. Ubhi, SS., Shaw, P., Wright, S., et al.[2022]

In a study of 82 patients undergoing their first thyroid fine-needle aspiration biopsy (TFNAB), listening to classical music significantly reduced anxiety levels during the procedure, as measured by the State Anxiety Inventory (SAI).

However, the music intervention did not have a significant effect on pain perception, as indicated by the visual analog scale (VAS), suggesting that while music can help with anxiety, it may not alleviate pain during medical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of classical music on anxiety and pain perception during a thyroid fine needle aspiration biopsy. Barlas, T., Sodan, HN., Avci, S., et al.[2023]

Using a stress ball during endoscopy significantly reduced patients' pain and anxiety levels after the procedure, based on a study of 60 patients split into two groups.

While pain scores before and during the procedure were similar between the stress ball and control groups, the stress ball group reported lower pain and anxiety after the procedure, suggesting that this simple distraction method can enhance patient comfort during medical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Using a Stress Ball During Endoscopy on Pain, Anxiety, and Satisfaction: A Randomized Controlled Trial. Karatas, TC., Gezginci, E.[2023]

In a study involving 96 adolescents, relaxation exercises significantly reduced fear and pain during PCR tests compared to stress balls and a control group, with the relaxation group reporting the lowest levels of post-procedure fear (0.09) and pain (0.44).

The findings suggest that relaxation exercises are an effective, accessible, and cost-effective method for alleviating anxiety and discomfort associated with invasive medical procedures in adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of stress ball and relaxation exercises on polymerase chain reaction (RRT-PCR) test-induced fear and pain in adolescents in Türkiye. Apaydin Cirik, V., Türkmen, AS., Ayaz, M.[2023]

In a study involving 123 children aged 8-12, both active (stress ball) and passive (audio-visual eyeglasses) distraction techniques during dental procedures reduced dental anxiety, but did not significantly outperform basic behavior guidance without distraction.

Despite the decrease in anxiety scores across all groups, there were no significant differences in behavior ratings or pain levels among the different distraction methods, indicating that while distractions may help, they do not necessarily enhance overall treatment experience compared to standard methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of active and passive distraction techniques while administering local anaesthesia on the dental anxiety, behaviour and pain levels of children: a randomised controlled trial. Shekhar, S., Suprabha, BS., Shenoy, R., et al.[2022]

An 8-week stress management intervention significantly reduced anti-thyroglobulin (anti-TG) antibody levels in women with Hashimoto's thyroiditis, suggesting a potential benefit in managing autoimmune thyroid conditions.

Participants in the stress management group also experienced notable improvements in stress, depression, anxiety levels, and overall lifestyle, indicating that stress management can positively impact both mental health and thyroid function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stress Management in Women with Hashimoto's thyroiditis: A Randomized Controlled Trial. Markomanolaki, ZS., Tigani, X., Siamatras, T., et al.[2022]

In a study of 30 adolescents aged 10 to 16 with type 1 diabetes, the use of primary control coping strategies, like problem solving and emotional expression, was linked to better quality of life, higher competence, and improved metabolic control.

Conversely, disengagement coping strategies, such as withdrawal or denial, were associated with lower competence and poorer metabolic control, highlighting the importance of adaptive coping strategies in managing diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coping and resilience in adolescents with type 1 diabetes. Jaser, SS., White, LE.[2022]

The study involved five poorly controlled female adolescents with diabetes, aged 15 to 18, who underwent anxiety management training over a 6-month period, showing that managing stress and anxiety can lead to better diabetic control.

Despite improvements in diabetic regulation indicated by lower and more stable urine glucose levels, the subjects did not report a decrease in their personal feelings of tension and anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of anxiety management training on the control of juvenile diabetes mellitus. Rose, MI., Firestone, P., Heick, HM., et al.[2019]

Individuals with Hashimoto disease in the euthyroid phase have a significantly higher risk of mood and anxiety disorders, including a 6.6 times greater likelihood of experiencing depressive episodes and a 20 times higher risk of social phobia compared to controls.

The study suggests that the association between mood and anxiety disorders in Hashimoto disease is independent of thyroid function, indicating that even when thyroid hormone levels are normal, individuals may still be at risk for these psychiatric conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A case control study on psychiatric disorders in Hashimoto disease and Euthyroid Goitre: not only depressive but also anxiety disorders are associated with thyroid autoimmunity. Carta, MG., Hardoy, MC., Carpiniello, B., et al.[2020]

Adults with Type 1 diabetes (T1D) experience a relentless burden from continuous self-management tasks, which significantly affect their coping experiences.

Utilizing technology, expert-led online support, and peer support can help ease the challenges of living with T1D, suggesting these resources should be prioritized in interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"No-one realises what we go through as Type 1s": A qualitative photo-elicitation study on coping with diabetes. Nettleton, JA., Burton, AE., Povey, RC.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effect of an Information Video before Thyroid Biopsy on Patients' Anxiety. [2022]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Effectiveness of stress management in patients undergoing transrectal ultrasound-guided biopsy of the prostate. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Imaging-Guided Core-Needle Breast Biopsy: Impact of Meditation and Music Interventions on Patient Anxiety, Pain, and Fatigue. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Anxiety in patients with symptomatic breast disease: effects of immediate versus delayed communication of results. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

The impact of classical music on anxiety and pain perception during a thyroid fine needle aspiration biopsy. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

The Effect of Using a Stress Ball During Endoscopy on Pain, Anxiety, and Satisfaction: A Randomized Controlled Trial. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of stress ball and relaxation exercises on polymerase chain reaction (RRT-PCR) test-induced fear and pain in adolescents in Türkiye. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Effect of active and passive distraction techniques while administering local anaesthesia on the dental anxiety, behaviour and pain levels of children: a randomised controlled trial. [2022]

9. Greece pubmed.ncbi.nlm.nih.gov

Stress Management in Women with Hashimoto's thyroiditis: A Randomized Controlled Trial. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Coping and resilience in adolescents with type 1 diabetes. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

The effects of anxiety management training on the control of juvenile diabetes mellitus. [2019]

12. United Arab Emirates pubmed.ncbi.nlm.nih.gov

A case control study on psychiatric disorders in Hashimoto disease and Euthyroid Goitre: not only depressive but also anxiety disorders are associated with thyroid autoimmunity. [2020]

13. Ireland pubmed.ncbi.nlm.nih.gov

"No-one realises what we go through as Type 1s": A qualitative photo-elicitation study on coping with diabetes. [2022]