Solid CancersCALM-WBNCT07653035
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 study testing Weighted Blanket and Regular Hospital Blanket in people with Solid Cancers and Anxiety Depression, run by Sultan Qaboos Comprehensive Cancer Center at 1 site in Oman.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Cancers, Anxiety Depression, Stress
- What is being tested?
- Weighted Blanket and Regular Hospital Blanket
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteOman
- Study dates
- 25 Dec 2025to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Oman1 site, 1 recruiting
- Recruiting
Sultan Qaboos Comprehensive Cancer Care and Research Center - University Medical City
Muscat, Seeb, 123
Aida M Al Kindy, Masters, +96897655101, a.alkindy@cccrc.gov.om
Fatma K Al Farsi, BScN, +96892893736, f.alfarsi@cccrc.gov.om
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Solid Cancers, Anxiety Depression, Stress
- Being tested
- Weighted Blanket, Regular Hospital Blanket
- Keywords
- blankets, cancer, anxiety, depression, comfort, intravenous infusion, non-pharmacological intervention
- Medical subject headings
- Neoplasms, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weighted BlanketDevice
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.
Regular Hospital BlanketDevice
This is a regular hospital blanket which is offered as standard of care to all patients. Patients will choose to apply if needed.
| Study group | Role | What they receive |
|---|---|---|
| Weighted Blanket Arm | Experimental | Receives Weighted Blanket Receives: Device: Weighted Blanket |
| Regular Hospital Blanket (No Weighted Blanket) | Active comparator | Patients are offered a regular blanket as per standard of care. Receives: Device: Regular Hospital Blanket |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Anxiety Using Visual Analog Scale for Anxiety (VAS-A)
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.
Measured: 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.
Change in Symptom Burden Using Edmonton Symptom Assessment System Revised (ESAS-r)
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.
Measured: 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.
Change in Depression, Anxiety, and Stress Using Depression Anxiety Stress Scales (DASS-21)
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.
Measured: 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.
Secondary outcomes (6)
Patient Satisfaction with Weighted Blanket Use (6-item Likert Scale)
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.
Measured: 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.
Change in Heart Rate
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.
Measured: 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.
Feasibility of Weighted Blanket Use Among Nurses (Feasibility Questionnaire)
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)
Measured: 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.
Change in Blood Pressure
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.
Measured: Pre-infusion and post-infusion during Cycle 1, Cycle 2, and Cycle 3 (14-28 days per cycle depending on standard care).
Change in Respiratory Rate
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.
Measured: Pre-infusion and post-infusion during Cycle 1, Cycle 2, and Cycle 3 (14-28 days per cycle).
Change in Body Temperature
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.
Measured: Pre-infusion and post-infusion during Cycle 1, Cycle 2, and Cycle 3 (14-28 days per cycle).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start25 Dec 2025
- Primary completionJun 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid CancersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sultan Qaboos Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Huda S Al Awaisi, PhD, Study director, Sultan Qaboos Comprehensive Cancer Care and Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07653035
- Sponsor's protocol ID
- CALM-WB
- Other IDs
- CCRC-56-2024 - a
- Acronym
- CALM-WB
- Status last verified
- Jun 2026
- First submitted
- 7 May 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07653035
- Acronym / sponsor ID
- CALM-WB / CALM-WB
- Conditions
- Solid Cancers, Anxiety Depression, Stress
- Keywords
- blankets, cancer, anxiety, depression, comfort, intravenous infusion, non-pharmacological intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Sultan Qaboos Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 25 Dec 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 17 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weighted Blanket Arm | Experimental | Device: Weighted BlanketReceives Weighted Blanket |
| Regular Hospital Blanket (No Weighted Blanket) | Active comparator | Device: Regular Hospital BlanketPatients are offered a regular blanket as per standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weighted BlanketWeighted 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. | Device | Weighted Blanket Arm |
| Regular Hospital BlanketThis is a regular hospital blanket which is offered as standard of care to all patients. Patients will choose to apply if needed. | Device | Regular Hospital Blanket (No Weighted Blanket) |
Primary outcome
Change in Anxiety Using Visual Analog Scale for Anxiety (VAS-A)
Time frame: 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.
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.
Change in Symptom Burden Using Edmonton Symptom Assessment System Revised (ESAS-r)
Time frame: 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.
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.
Change in Depression, Anxiety, and Stress Using Depression Anxiety Stress Scales (DASS-21)
Time frame: 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.
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.
6 secondary outcomes
Patient Satisfaction with Weighted Blanket Use (6-item Likert Scale)
Time frame: 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.
Change in Heart Rate
Time frame: 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.
Feasibility of Weighted Blanket Use Among Nurses (Feasibility Questionnaire)
Time frame: 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.
Change in Blood Pressure
Time frame: Pre-infusion and post-infusion during Cycle 1, Cycle 2, and Cycle 3 (14-28 days per cycle depending on standard care).
Change in Respiratory Rate
Time frame: Pre-infusion and post-infusion during Cycle 1, Cycle 2, and Cycle 3 (14-28 days per cycle).
Change in Body Temperature
Time frame: Pre-infusion and post-infusion during Cycle 1, Cycle 2, and Cycle 3 (14-28 days per cycle).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr. Huda S Al Awaisi, PhD study director
Sultan Qaboos Comprehensive Cancer Care and Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weighted Blanket and Regular Hospital Blanket in people with Solid Cancers and Anxiety Depression, run by Sultan Qaboos Comprehensive Cancer Center at 1 site in Oman.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Oman. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aida M Al Kindy, BScN, MQM (+968-97655101, a.alkindy@cccrc.gov.om), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Anxiety Using Visual Analog Scale for Anxiety (VAS-A) (time frame: 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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.