The Effect of Using Weighted Blanket on Anxiety, Stress, Depression and Comfort Level Among Patients With Cancer Undergoing Intravenous Anticancer Therapy and Its Feasibility of Use by Nurses Compared to Routine Care (CALM-WB)
The Effect of Using Weighted Blanket on Anxiety, Stress, Depression and Comfort Level Among Patients With Cancer Undergoing Intravenous Anticancer Therapy and Its Feasibility of Use by Nurses Compared to Routine Care; a Randomized Controlled Study (CALM-WB)
Protocol Title: Protocol Title: The Effect of using Weighted Blanket on anxiety, stress, depression and comfort level among Patients with cancer undergoing intravenous (IV) anticancer therapy and its feasibility of use by nurses compared to routine care; a Randomized controlled study.
Study Tools: VAS-A, ESAS-R, DASS-21 and comfort level scale will be used to study the patients' population. A survey will be used to assess the feasibility of using the weighted blankets on patients receiving IV anticancer therapy.
Methodology: Consented patients will be stratified per gender then randomized to either ARM1: The interventional arm, Weighted blanket, or ARM2: The control arm, Standard of care. (Regular blanket). The weighted blanket will be administered in the two cycles of IV anticancer therapy for the interventional arm, exploring the temporal trajectory of anxiety, depression, and psychological distress, and investigating the potential of a weighted blanket intervention to mitigate these symptoms. The tools will be administered according to the study protocol. Day Care Unit nurses will be assessed on how feasible they think the blankets are for patients. Expected Outcome: WB is expected to reduce the anxiety in patients undergoing IV anticancer therapy and reduce the nurses' burden when caring for those patients.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Cancer represents a significant public health concern in the Sultanate of Oman and continues to contribute substantially to morbidity and mortality within the population. According to the Ministry of Health (2020), cancer is the fourth leading cause of death in the country, highlighting its considerable and growing burden. The crude incidence rate among Omanis is estimated at 68.3 per 100,000 among males and 79.4 per 100,000 among females, indicating a slightly higher incidence among women.
Among the different types of cancer, breast cancer is the most common, with approximately 35% of cases diagnosed at advanced stages (stage III or IV), which is associated with poorer prognostic outcomes and increased physical and psychological burden. Thyroid cancer and colorectal cancer also contribute significantly to the overall cancer burden in the country.
The management of cancer involves a range of treatment modalities aimed at curing the disease, prolonging survival, or improving quality of life. These include surgery, radiotherapy, and systemic therapies such as chemotherapy, immunotherapy, and hormonal treatments. Among these, chemotherapy remains one of the most widely used approaches due to its effectiveness in targeting malignant cells.
However, despite its benefits, chemotherapy is associated with various adverse effects that can negatively impact both the physical and psychological well-being of patients.
Patients undergoing chemotherapy frequently experience distressing physical symptoms, including nausea, fatigue, pain, and general discomfort. In addition to these physical effects, chemotherapy also has a significant psychological impact.
Anxiety is consistently reported as the most common psychological symptom among cancer patients receiving chemotherapy. This anxiety is multifactorial in nature and may arise from concerns about treatment side effects, fear of disease progression, changes in body image such as hair loss, and disruptions to daily activities and social roles.
Anxiety levels are not constant across the cancer trajectory but tend to fluctuate depending on different stages of the disease and treatment process. At the time of diagnosis and treatment planning, patients often experience heightened emotional distress due to uncertainty and fear of the unknown. During the treatment phase, persistent physical symptoms and repeated chemotherapy cycles may sustain or even intensify anxiety levels. Additional triggers such as scan results, treatment modifications, and worsening symptoms can further exacerbate anxiety. Individual factors, including age, coping strategies, and prior mental health status, also play an important role in influencing the severity of anxiety experienced.
Unmanaged anxiety can have serious consequences on patient outcomes. It may lead to reduced adherence to treatment, lower satisfaction with care, and diminished quality of life. Furthermore, psychological distress, which encompasses emotional, cognitive, and social dimensions, is common among cancer patients and may manifest as fear, hopelessness, or social withdrawal. Evidence suggests that approximately one-quarter of patients undergoing chemotherapy experience anxiety and depression, which have been linked to poorer clinical outcomes and reduced survival rates.
In response to this burden, increasing attention has been given to non-pharmacological interventions aimed at improving patients' psychological well-being. These interventions include relaxation techniques, music therapy, psychoeducation, and cognitive behavioral therapy. Such approaches are particularly valuable as they provide supportive care without adding to the pharmacological burden or introducing additional side effects.
Deep touch pressure (DTP) has recently emerged as a promising intervention for reducing anxiety and promoting relaxation. It involves the application of gentle, sustained tactile pressure, which has been shown to enhance parasympathetic activity and reduce sympathetic nervous system arousal, thereby supporting emotional regulation and a sense of calm. A practical application of DTP is the use of weighted blankets, which provide evenly distributed pressure to create a soothing "cocooning" effect and promote relaxation and improved sleep.
Growing evidence supports the effectiveness of weighted blankets in reducing anxiety across various populations, including individuals in clinical settings. In oncology, emerging studies suggest that weighted blankets can reduce anxiety during chemotherapy sessions and are generally well accepted by both patients and healthcare providers due to their ease of use and feasibility.
Despite this growing evidence, research on the use of weighted blankets among cancer patients in Middle Eastern populations remains limited. Therefore, this study aims to evaluate the effectiveness of weighted blankets as a non-pharmacological intervention to reduce anxiety in cancer patients undergoing chemotherapy.
The study adopts a randomized controlled trial design. Participation is voluntary, and written informed consent will be obtained from all participants. Patients will be stratified by gender due to its recognized influence on anxiety reporting. Following stratification, participants will be randomly assigned to either the intervention group, which will receive the weighted blanket, or the control group. Randomization will be conducted using a computer-generated system to ensure methodological rigor.
Statistical analysis will include comparisons between the intervention and control groups using appropriate tests, with a significance level set at p ≤ 0.05. The study is powered to detect a meaningful effect, with a total sample size of 152 patients equally distributed across study groups and gender strata.
This study offers a practical and innovative approach to addressing anxiety among patients undergoing chemotherapy. By evaluating a simple, cost-effective, and non-pharmacological intervention such as weighted blankets, the study has the potential to enhance patient well-being and support the integration of holistic care in oncology settings.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Aida M Al Kindy, BScN, MQM
- Número de teléfono: +968-97655101
- Correo electrónico: a.alkindy@cccrc.gov.om
Copia de seguridad de contactos de estudio
- Nombre: Fatma K Al Farsi, BScN
- Número de teléfono: +96892893736
- Correo electrónico: f.alfarsi@cccrc.gov.om
Ubicaciones de estudio
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Seeb
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Muscat, Seeb, Omán, 123
- Reclutamiento
- Sultan Qaboos Comprehensive Cancer Care and Research Center - University Medical City
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Contacto:
- Fatma K Al Farsi, BScN
- Número de teléfono: +96892893736
- Correo electrónico: f.alfarsi@cccrc.gov.om
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Contacto:
- Aida M Al Kindy, Masters
- Número de teléfono: +96897655101
- Correo electrónico: a.alkindy@cccrc.gov.om
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Investigador principal:
- Aida M Al Kindy, Masters
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Sub-Investigador:
- Dr. Huda S Al, PhD
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Sub-Investigador:
- Fatma K Al Farsi, BScN
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria: for patients
- Newly diagnosed cancer patients aged 18 years and older.
- Receiving first-line intravenous anticancer therapy (chemotherapy or immunotherapy or a combination of both) in the daycare unit (adjuvant, neoadjuvant, or palliative).
- Weighting at least 55 kg during obtaining the informed consent. (At least 54 kg before the intervention).
- Able to complete study assessments.
- Speaks Arabic or English.
- Signs Informed consent.
Exclusion Criteria for patients:
- Prior psychological treatment or psychotherapy (confirmed psychological diagnosis, history of psychotropic medications and previous psychotherapy).
- Currently hospitalized in inpatient units.
- Patients on daily anticancer infusions.
- Positive fall risk assessment.
- Open wounds and recent surgeries/ stoma.
- Enrolled in any other device study or clinical trial during data collection.
History of:
- Diabetes mellitus
- Respiratory disorders,
- Claustrophobia (Miller et al 2003) Because of the possibility for altered sensory perception,
- Patients who had a diagnosis of peripheral neuropathy or fibromyalgia (Vinson et al. 2020)
- Cognitive impairment
Eligibility criteria for the nurse's population:
Day Care Unit nurses will be recruited by convenient sampling and feedback will be sought per patient per visit. The reason to this is because the same nurses maybe caring for multiple patients using the WBs and each patient will provide a different experience for the nurses caring for those patients. Only nurses who agree to complete the study questionnaire will be included.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Weighted Blanket Arm
Receives Weighted Blanket
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Weighted blankets selection was done to ensure the weight is below 10% of the participants' average weight.
For the purpose of this study, researchers will use the 12 lbs (equivalent to 5.44 kg) blankets to account for less than 10% of the patients' average weight.
The blankets do not come in free size (Field et.
al. 2010).
The manufacturer selected was Sommerfly, mainly because of suitability of the product for clinical use (infection control recommendations) and ease of shipping of the products.
The blankets are waterproof, breathable, tear-resistant, antimicrobial, flame-resistant and non-toxic.
Cleaning involves wiping the surface with approved cleaning wipes or mild soap and water, followed by rinsing and air-drying.
If disinfection is required, a 10% bleach solution may be used.
Machine washing, drying, or dry cleaning is not permitted.
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Comparador activo: Regular Hospital Blanket (No Weighted Blanket)
Patients are offered a regular blanket as per standard of care.
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This is a regular hospital blanket which is offered as standard of care to all patients.
Patients will choose to apply if needed.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Anxiety Using Visual Analog Scale for Anxiety (VAS-A)
Periodo de tiempo: Baseline (prior to weighted blanket use) and at the end of Cycle 1 and Cycle 2 (each cycle is 14 days to 28 days) depending on the prescribed cycle length as per standard of care, of intravenous anticancer therapy.
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Anxiety will be measured using the Visual Analog Scale for Anxiety (VAS-A).
The scale ranges from 0 to 10, where 0 indicates no anxiety and 10 indicates worst possible anxiety.
Higher scores represent worse anxiety.
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Baseline (prior to weighted blanket use) and at the end of Cycle 1 and Cycle 2 (each cycle is 14 days to 28 days) depending on the prescribed cycle length as per standard of care, of intravenous anticancer therapy.
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Change in Symptom Burden Using Edmonton Symptom Assessment System Revised (ESAS-r)
Periodo de tiempo: Baseline (prior to weighted blanket use) and at the end of Cycle 1 and Cycle 2 (each cycle is 14 days to 28 days) depending on the prescribed cycle length as per standard of care, of intravenous anticancer therapy.
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Symptoms will be assessed using the Edmonton Symptom Assessment System Revised (ESAS-r), a validated tool measuring multiple symptoms (e.g., pain, fatigue, anxiety, depression).
Each symptom is scored from 0 to 10, where higher scores indicate worse symptom severity.
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Baseline (prior to weighted blanket use) and at the end of Cycle 1 and Cycle 2 (each cycle is 14 days to 28 days) depending on the prescribed cycle length as per standard of care, of intravenous anticancer therapy.
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Change in Depression, Anxiety, and Stress Using Depression Anxiety Stress Scales (DASS-21)
Periodo de tiempo: Baseline and on Cycle 3 - At any timepoint during the visit (each cycle is anywhere between 14 days and 28 days) of intravenous anticancer therapy.
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Psychological status will be assessed using the Depression Anxiety Stress Scales (DASS-21), which includes three subscales: depression, anxiety, and stress.
Each subscale score ranges from 0 to 42 after multiplication, with higher scores indicating worse psychological distress.
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Baseline and on Cycle 3 - At any timepoint during the visit (each cycle is anywhere between 14 days and 28 days) of intravenous anticancer therapy.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Patient Satisfaction with Weighted Blanket Use (6-item Likert Scale)
Periodo de tiempo: Given to participants randomized to the weighted blanket arm at the end of Cycle 1 and Cycle 2 (each cycle is 14 days to 28 days), depending on the prescribed cycle length as per standard of care, of intravenous anticancer therapy.
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Patient satisfaction with the weighted blanket will be assessed using a 6-item questionnaire. Each item is rated on a 3-point Likert scale (0 = Disagree, 1 = Not Sure, 2 = Agree). The total score ranges from 0 to 12, calculated by summing responses across all six items. Higher scores indicate greater patient satisfaction with the weighted blanket. The questionnaire was developed for this study and underwent internal validation for clarity and content by a group of individuals who assessed the items for understandability and relevance prior to study implementation. |
Given to participants randomized to the weighted blanket arm at the end of Cycle 1 and Cycle 2 (each cycle is 14 days to 28 days), depending on the prescribed cycle length as per standard of care, of intravenous anticancer therapy.
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Change in Heart Rate
Periodo de tiempo: Pre-infusion and post-infusion during Cycle 1, Cycle 2 and cycle 3. (each cycle is 14 days to 28 days) depending on the prescribed cycle length as per standard of care, of intravenous anticancer therapy.
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Heart rate will be measured in beats per minute (bpm) before and after intravenous anticancer therapy.
The change from pre-infusion to post-infusion will be calculated and compared between the interventional and control groups.
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Pre-infusion and post-infusion during Cycle 1, Cycle 2 and cycle 3. (each cycle is 14 days to 28 days) depending on the prescribed cycle length as per standard of care, of intravenous anticancer therapy.
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Feasibility of Weighted Blanket Use Among Nurses (Feasibility Questionnaire)
Periodo de tiempo: Given to nurses caring for participants randomized to the weighted blanket arm at the end of Cycle 1 and Cycle 2 (each cycle is 14 days to 28 days), depending on the prescribed cycle length as per standard of care, of intravenous anticancer therapy.
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Feasibility will be assessed using a structured questionnaire completed by nurses, evaluating ease of use, safety, and practicality.
Responses will be recorded on a Likert scale.
(Disagree 0, Not sure 1, Agree 2)
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Given to nurses caring for participants randomized to the weighted blanket arm at the end of Cycle 1 and Cycle 2 (each cycle is 14 days to 28 days), depending on the prescribed cycle length as per standard of care, of intravenous anticancer therapy.
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Change in Blood Pressure
Periodo de tiempo: Pre-infusion and post-infusion during Cycle 1, Cycle 2, and Cycle 3 (14-28 days per cycle depending on standard care).
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Blood pressure (mmHg) will be measured before and after intravenous anticancer therapy.
Changes from pre-infusion to post-infusion will be calculated and compared between study groups.
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Pre-infusion and post-infusion during Cycle 1, Cycle 2, and Cycle 3 (14-28 days per cycle depending on standard care).
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Change in Respiratory Rate
Periodo de tiempo: Pre-infusion and post-infusion during Cycle 1, Cycle 2, and Cycle 3 (14-28 days per cycle).
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Respiratory rate will be measured in breaths per minute before and after intravenous anticancer therapy.
The change from pre- to post-infusion will be compared between the interventional and control groups.
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Pre-infusion and post-infusion during Cycle 1, Cycle 2, and Cycle 3 (14-28 days per cycle).
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Change in Body Temperature
Periodo de tiempo: Pre-infusion and post-infusion during Cycle 1, Cycle 2, and Cycle 3 (14-28 days per cycle).
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Body temperature (°C) will be recorded before and after intravenous anticancer therapy.
The change from pre- to post-infusion will be analyzed and compared between groups.
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Pre-infusion and post-infusion during Cycle 1, Cycle 2, and Cycle 3 (14-28 days per cycle).
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Dr. Huda S Al Awaisi, PhD, Sultan Qaboos Comprehensive Cancer Care and Research Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CALM-WB
- CCRC-56-2024 - a (Otro identificador: Sultan Qaboos Comprehensive Cancer Care and Research Center)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
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Ensayos clínicos sobre Weighted Blanket
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Universiteit AntwerpenUniversity Hospital, Antwerp; Fund for Scientific Research, Flanders, BelgiumReclutamientoDolor crónico | Neoplasia De Mama | Carcinoma de mamaBélgica