Protocol for Using a Weighted Blanket to Treat Anxiety Related to Trying New Foods in the Pediatric Population
Phase: NA
Conditions: Food Neophobia, Picky Eating, Avoidant Restrictive Food Intake Disorder, Anxiety State
Sponsor: The University of Texas Medical Branch, Galveston

IRB Protocol Version 4 
IRB # 23-0342 
4/16/2024 
Protocol for Using a Weighted Blanket to Treat Anxiety Related to Trying New Foods in  
the Pediatric Population 
Principal Investigator: Heather Celkis, OTR 
Faculty Sponsor: Claudia Hilton, PhD, MBA, OTR, FAOTA 
University of Texas Medical Branch 
Department of Occupational Therapy 
301 University Blvd. Galveston, TX 77555 
 

IRB Protocol Version 1 
Table of Contents 
Study Schema 
1.0 Background 
2.0 Rationale and Specific Aims 
3.0 Inclusion/Exclusion Criteria 
4.0 Enrollment and Consenting Process 
5.0 Study Procedures 
6.0 Study Product Description 
7.0 Potential Risk 
8.0 Subject Safety 
9.0 Data Monitoring and Participant Confidentiality 
10.0 Potential Benefits 
11.0 Study Withdrawal/Discontinuation 
12.0 Biostatistics and Subsidies 
13.0 References 
SIGNATURE PAGE 
The signature below constitutes the approval of this protocol and the attachments and provides 
the necessary assurances that this trial will be conducted according to all stipulations of the 
protocol, including all statements regarding confidentiality, and according to local legal and 
regulatory requirements and applicable US federal regulations and ICH guidelines. 
Site Investigator:* 
Signed:                                                                                              Date: 

(name and title) 
 

1.0 Background 
Exploring and eating food is one of the most critical occupations for children. However, 
some children experience challenges impacting their ability to interact with food in a healthy 
way. Feeding challenges can negatively impact a child’s quality of life and health (Cunliffe et al., 
2022). 
There are many reasons that children do not eat the variety and amount of foods required 
for optimum health. Some children have structural, neurological, or medical challenges 
impacting their ability to tolerate foods (Kamarudin et al., 2023).  For optimal outcomes, these 
areas must be addressed and treated. However, following treatment, sometimes difficulty 
accepting food remains.   
Food Avoidance 
Food avoidance can occur within nonclinical and clinical populations (Cunliffe et al., 
2022; Chao, 2018). Diagnoses or terms used to describe children who have challenges eating a 
variety of foods and trying new foods include picky eaters, children with food neophobia, and 
avoidant/restrictive food intake disorder (ARFID).  A child presents with picky eating (PE) when 
they eat a limited variety of foods, have rigidity around the sensory qualities of food, and 
demonstrate difficulty trying new foods (Barnhart et al., 2021).  PE is not a medically defined 
term but describes restrictive food intake behavior common among children (Chao, 2018).  
Taylor and Emmett (2019) discuss the prevalence of PE among toddlers and state that 
food-related behavior in infants under 12 months should not be considered PE or neophobia due 
to their lack of experience with food. Cardona Cano et al. (2015) completed a study including 
4,018 participants examining the trajectory of PE in childhood. At age 1.5 years, 26.5% of 
children were reported to have PE behavior, and at age 3, parents reported a slight increase to 

27.6%. However, at age 6, only 13.2% of children had reported PE behavior. The authors 
cautiously speculated that PE behaviors at age 6 suggest risk factors for worse health outcomes 
than children without a history of PE. While transient PE may be part of typical development in 
the toddler and preschool years, persistent and severe PE will likely lead to poor health 
outcomes. It is estimated that PE is common and ranges from 25% to 53%, with statistics 
differing by country (Kamarudin et al., 2023).  
Food neophobia relates to the fear and avoidance of novel foods and can relate to visual 
attention bias toward the food (Maiz & Balluerka, 2018). Hazley et al. (2022) completed a study 
and found that food neophobia peaked at approximately age 6. The prevalence of food neophobia 
is not widely understood due to no universal way of measuring and defining food neophobia 
(Białek-Dratwa et al., 2022). 
  
According to the Diagnostic and Statistical Manual of Mental Disorders 5th edition 
(2022), the diagnosis of ARFID captures a wide variety of feeding disturbances and leads to 
inference with psychosocial functioning and failure to meet nutritional and energy needs. Dinkler 
et al. (2022) found that children at risk for ARFID began to demonstrate more food-avoidant 
behaviors than their peers during toddlerhood. Sanchez 
Cerezo et al. (2022) completed a 
systematic review to understand the epidemiology of ARFID. They found that most studies 
reported a prevalence rate between 5%-22.5%. Anxiety disorders were found to be common 
within the population of children and adolescents diagnosed with ARFID studied, ranging from  
9.1%-72%.  
Impact of Feeding and Eating Challenges 
Anxiety surrounding food can be debilitating for a child. Difficulties tolerating a variety 
of foods due to anxiety can negatively impact many areas of a child’s life, including nutrition, 

energy, self-esteem, self-regulation, and social interactions (Maiz & Balluerka, 2018). 
Selfregulation’s definition can vary based on the theoretical framework as noted within cognitive 
learning and sensory integration theories (Martini et al., 2016). Kuypers (2013) defined 
selfregulation as obtaining and maintaining an optimal level of alertness to function. Kuypers 
also included the ability to manage emotions and sensory needs to participate in occupations such 
as schoolwork and activities of daily living as part of self-regulation.  
Shree and Murthy (2021) completed a study and concluded that there is a significant 
association between scholastic performance and nutritional status. Zickgraf and Elkins (2018) 
discussed how PE is problematic from both a psychosocial and nutritional standpoint.  Maiz & 
Balluerka (2018) found that children with food neophobia scored lower on the social and family 
dimensions of self-concept than their peers. 
 In addition, parents of children who experience anxiety surrounding food report increased stress 
(Cunliffe et al., 2022). Zickgraf and Elkins (2018) stated that parents of children with PE 
experience anxiety, stress, and family conflict. Kim et al. (2021) completed a study examining 
parent strategies for expanding food variety and perceptions of helpfulness as reported by adults 
with symptoms of ARFID. The study found that while strategies to increase the pleasure of the 
eating experience could make a positive change, forceful strategies were not perceived as 
helpful.  
Children’s feeding difficulties and food avoidance are significant concerns for parents and 
healthcare providers. Food avoidance can impact a child’s growth, physical well-being, and 
health later in life (Zickgraf & Elkins, 2018). Grey et al. (2021) completed a systematic review to 
understand the effects of famine and food restriction on children as they grew to adulthood. They 

found a consistent association between significant childhood malnutrition with adult increased 
risk for cardiovascular disease, metabolic syndrome, and hypertension. While children with food 
avoidance behavior do not have forced food restrictions, such as children experiencing a famine, 
malnutrition due to poor intake of vegetables and proteins limits their nutritional health and 
micronutrient intake (Kamarudin et al., 2023). In addition, Padhani et al. (2022) discussed how 
malnutrition can contribute to a weakened immune system.  
Anxiety and Picky Eating 
Anxiety appears to contribute to challenges with food tolerance for children with food 
neophobia, ARFID and PE. Zickgraf and Elkins (2018) completed a study to understand the 
relationship between anxiety, sensory sensitivity, and PE. They found that children who had 
identified anxiety demonstrated increased sensitivity to sensory input. Increased sensory 
sensitivity is predictive of PE behavior.  The researchers linked anxiety to both state and trait 
sensory sensitivity. It is unclear, per the study completed by Zickgraf and Elkins, if anxiety 
causes sensory sensitivity. Therefore, best practice requires the treatment of both anxiety and 
sensory sensitivity.   
Most research supports the concept that children with food avoidance also have anxiety 
and challenges with regulation. Maiz and Balluerka (2018) found that children with food 
neophobia scored higher on trait anxiety. State anxiety refers to a natural anxiety response to 
danger. This type of anxiety is experienced only when danger is present and is not related to an 
underlying anxiety condition. Trait anxiety describes someone who experiences anxiety most of 
the time as part of their personality, not only when presented with a trigger. Santos et al. (2022) 
completed a study suggesting that children’s emotion regulation predicted healthy food 
consumption. These studies support the hypothesis that treatment for children who are picky 

eaters supporting regulation and decreasing anxiety would improve healthy eating habits. 
IronSegev et al. (2020) generated research that showed more emotional disturbances occur in 
children with ARFID compared to the control group. In contrast, this study showed no significant 
difference between the control group and the group with an ARFID diagnosis on anxiety 
outcome measures.   
Researched Interventions 
Interventions that have been proven effective in helping children with neophobia tolerate 
foods include cognitive behavioral therapy, routine following, food exposure, sensory play, and 
tactile food exploration (Kamarudin et al., 2023; Thomas et al., 2020; Merritt & Caldwell, 2020; 
Garcia et al., 2020; Nekitsing et al., 2019; Karagiannaki et al., 2021). Beyond sensory play, limited 
recent studies exist regarding sensory strategies to calm during feeding. One article contained a 
randomized controlled trial and studied the use of mindful breathing techniques and mindful eating 
when trying new food. This study found that children ages 10-12 years old who used mindfulness 
techniques increased their intake of novel fruit but did not decrease their anxiety or food 
neophobia, as shown by outcome measures of the Food Situations Questionnaire and Spence 
Children’s Anxiety Scale Teddy Picture Rating Scale (Bennett et al., 2020). However, this was the 
only article on this subject, and it had many limitations, including a small number of participants. 
Using breathing techniques to calm children with food neophobia appears to lack research and 
warrants future study. 
Weighted Blankets 
  
Weighted blankets have increased in availability and popularity in recent years. A 
systematic review study found that weighted blankets reduce anxiety (Eron et al., 2020). 
Occupational therapy practitioners (OTP) use deep pressure techniques such as weighted 

blankets during treatment to improve a client’s ability to self-regulate and calm. A study 
including functional magnetic resonance imaging and a compression sleeve to provide deep 
pressure without human touch completed by Case et al. (2021) found that deep pressure was 
calming to the nervous system. Reynolds et al. (2015) completed a study examining deep 
pressure applied with an inflatable vest and found that participants who were stressed by a 
challenge experienced a decreased arousal level following the deep pressure.  Lane et al. (2012) 
had previously completed a study that positively correlated anxiety in children ages 6-10 years 
with sympathetic measures of arousal level. Lönn et al. (2023) found weighted blankets to 
improve sleep efficiency in children diagnosed with attention-deficit/hyperactivity disorder with 
a mean age of 9 years using a randomized controlled crossover trial. The children reported 
increased satisfaction with the weighted blanket compared to the control blanket. Meth et al. 
(2022) found that melatonin was secreted in young adults when provided with a weighted 
blanket at bedtime. Vinson et al. (2020) found that anxiety was reduced in people receiving 
chemotherapy who used a weighted blanket. Dickson et al. (2021) completed a small study 
where the participants in a psychiatric ward reported decreased anger and anxiety in their posttest 
scores. Becklund et al. (2021) produced a study that showed statistically significant decreases in 
anxiety in adults at an inpatient psychiatric facility who utilized a weighted blanket. Bolic Baric 
et al. (2021) examined the effectiveness of weighted blanket use on sleep and activities of daily 
living among participants with diagnoses of autism spectrum disorder and attention deficit 
hyperactivity disorder. They found that weighted blankets improved sleep at night and relaxation 
during the day. These studies further support the use of deep pressure as a treatment strategy for 
calming and regulation. Improved self-regulation can allow for improved participation in 
occupations such as eating.  

While no studies were found supporting the use of weighted blankets with children with 
anxiety-related food avoidance, the findings from the pilot randomized controlled trial completed 
by Ohene et al. (2022) found that weighted blankets combined with traditional occupational 
therapy (OT) may benefit adults diagnosed with anorexia nervosa and AFRID. The use of 
weighted blankets to calm children who experience food avoidance appears to be an area 
requiring study.  
2.0 Rationale and Specific Aims  
Contribution to Occupational Therapy 
Many children experience anxiety-related food avoidance, and there is a dearth of 
research on sensory strategies to address these difficulties. Researchers must explore intervention 
options to provide individualized and appropriate care for children with eating challenges related 
to anxiety. The fourth edition of the Occupational Therapy Practice Framework: Domain and 
Process describes well-being, health, and occupational engagement as central concepts of OT 
(American Occupational Therapy Association [AOTA], 2020). AOTA (2017) clarifies the role of 
the OTP within the occupation of eating, including providing environmental modifications. My 
aim for my capstone is to produce scholarly work and research to support these core OT values in 
pediatric feeding and expand on environmental modification treatment options. While Ohene et 
al. (2022) completed a pilot study examining the sensory strategy of weighted blankets with 
adults with ARFD and anorexia nervosa, no research has been published to understand if 
weighted blankets might be helpful for children with feeding issues. Completing research in 
pediatric food avoidance and treatment strategies provides additional evidence-based treatment 
options for OTPs to help children within this population.  

AOTA (2016) describes the importance of scholarship and creating new knowledge to 
contribute to the profession and society. Boyer (1990) describes the scholarship of discovery as a 
disciplined and structured investigation to gain understanding. I intend to research this topic 
without bias to provide novel information using a studied treatment strategy in an innovative 
way, thus participating in the scholarship of discovery. Furthermore, the OT Standards for 
Continuing Competence generated by AOTA (2015) demands that OTPs use evidence-based 
knowledge and critical reasoning skills to provide best-practice therapy. Therefore, the profession 
of OT must continue to provide cutting-edge research and add to the body of existing knowledge.  
Proposed Pilot Study 
This small experimental pilot study addresses the knowledge gap related to the use of 
weighted blankets for children with anxiety related to food and eating. My plan includes 
recruiting a minimum of seven children who receive OT treatment at the clinic where I work and 
clinics in the surrounding area. However, I would like permission to recruit twelve children due 
to concerns with attrition. The design of the study will include a control period prior to the 
treatment period. This study will seek to understand if children improve their ability to self 
regulate and calm with the use of a weighted blanket when trying new foods. It will also attempt 
to research whether children improve novel food consumption using a weighted blanket.    
3.0 Inclusion/Exclusion Criteria 
Subjects must meet all inclusion criteria to be eligible to participate in the study. 
Inclusion criteria are: 
1. Subject and guardian has provided informed consent in a manner approved by the IRB and is 
willing and able to comply with the trial procedures. 

2. Subject is receiving occupational therapy to treat identified feeding challenges  
3. Subject has anxiety related to food as reported by caregiver 
4. Subject is between the ages of 8-12 
5. Subject has good reading abilities 
6. Subject weighs 30 pounds or more 
Subjects meeting any of the exclusion criteria at baseline will be excluded from study 
participation. 
Exclusion Criteria are: 
1. 
Any medical condition that, in the opinion of the investigator, would place the subject at 
increased risk for participation due to the inability to remove the blanket safely. Examples of 
diagnoses that would exclude a participant include spinal cord injury, cerebral palsy, and 
muscular dystrophy.  
2.   Concurrent participation on another research study 
3.   Participants outside of the ages 8-12 
4.   Participants refuse to use the weighted blanket 
5. If the use of a weighted blanket is contraindicated for any reason 
6. Participants lacking the reading ability to complete a questionnaire 

7. Participants who weigh under 30 pounds per parent report and cannot use a commercially 
available weighted blanket as the minimum weight of a weighted blanket is 3 pounds will be 
excluded but this exclusion is unlikely due to the inclusion age range 
8. Participant is not currently receiving occupational therapy to address feeding difficulties 
4.0 Enrollment/Consenting Process 
Children receiving occupational therapy services at Capital Area Speech and 
Occupational Therapy to address feeding who have anxiety related to food will be offered 
enrollment via flyers and word of mouth. The first level of recruitment will include potential 
participants that have a patient relationship with the principal investigator or are receiving 
occupational therapy services from another occupational therapist at Capital Area Speech and 
Occupational Therapy.  If 12 participants meeting the inclusion criteria cannot be recruited from 
Capital Area Speech and Occupational Therapy, the second level of recruitment will occur 
including other clinics in the Austin, Texas area who have given permission for flyers to be left in 
their waiting rooms. During the second level of recruitment, potential participants will contact 
the principal investigator for additional information regarding the study. A flyer will be available 
to potential participants with information about the study and principal investigator’s contact 
information so that caregivers can ask questions. Potential study participants will only be 
provided additional information upon request regarding the study.  
Recruitment will take place for 2 months and is anticipated to start April 2024 following 
IRB approval with researchers determining eligibility for the study based on inclusion and 
exclusion criteria. Participants and at least one guardian of each participant will be required to 
sign a consent form to affirm that they understand the purpose of this study, risks, and 

requirements. To respect potential participant privacy, no information will be collected for 
research purposes prior to consent form completion. Also, no information of participants who 
withdraw from this study will be used. To consent to this study, potential participants will be 
provided with a consent form to review via email prior to signing it. Potential participants will be 
given an opportunity to speak with the investigator prior to signing the consent form. 
No randomization will take place. There will be a control period consisting of usual care 
occupational therapy lasting 1 month prior to the treatment period lasting 1 month.  
5.0 Study Procedures 
1. Recruitment 
2. Consent 
3. Enrollment of participants based on inclusion and exclusion criteria.  
4. Guardians of enrolled participants will complete the baseline outcome measure 
Food Neophobia Scale for Children (FNSC) questionnaire consisting of 10 questions 
(Pliner, 1994). Guardians of participants will also complete an initial food list on the 
initial food log form including all foods that the participant currently tolerates. Included 
on the initial food log form will be a place for the caregiver to record the age and weight 
of the child. The weight of the child will be used to calculate the appropriate weight of 
the weighted blanket. The weighted blanket will not exceed 10% of the child’s body 
weight. Weighted blankets are commercially available through the company yescool for 
children in weights of ten pounds, seven pounds, five pounds, and three pounds. Each 
participant will receive a weighted blanket that is approximately 10% of their body 

weight but does not exceed 10% of their body weight. For example, if a child weighs 55 
pounds, they will receive a five-pound weighted blanket. The initial food log form 
including the initial food list and weight of the child will be scanned and returned to the 
caregiver prior to the control period. The FNSC will be collected. 
5. Participants will receive occupational therapy services treatment as usual without use 
of a weighted blanket for 1 month. During this period, participants will complete the S-
Anxiety scale of the State-Trait Anxiety Inventory for Children (STAIC) three times 
per week upon sitting at the table prior to a meal (Spielberger, 1973). The S-Anxiety 
scale questionnaire will take about 8-12 minutes for a child to complete the first time 
and 5-8 minutes for repeated administrations. All forms and scales necessary for the 
control period will be provided to the caregivers prior to the control period of the 
study. 
6. After the 1-month control period, caregivers will complete the FNSC and complete the 
second food list adding any new foods to the initial food log (Pliner, 1994). The 
principal investigator will collect the FNSC and the initial food log form at this time.  
7. Following the 1-month control period, participants and their guardians will receive a 
weighted blanket with verbal and written instructions for use and safety. The 
participants will continue usual care occupational therapy treatment during the 
treatment period. The caregivers will be provided with copies of the S-Anxiety scale of 
the STAIC, new food log, and a copy of the initial food log for reference (Spielberger, 
1973). Participants will be instructed to use the weighted blanket for at least 5 minutes 
and no more than 15 minutes while participating in a quiet enjoyable activity prior to a 
meal with guardian supervision. Guardians will be responsible to keep the weighted 
blanket when not in use. Due to busy family schedules, it may not be possible to use 

the blanket daily, therefore, the family will be asked to offer use of the blanket a 
minimum of 3 meals a week. On the days that the weighted blanket was used, the 
participant will complete the S-Anxiety scale of the STAIC at the table where they will 
consume the meal, following using the blanket and before eating the food (Spielberger, 
1973).  The guardians will be asked to record any new foods tried during the meal on 
the new food log along with the date each time the participant uses the weighted 
blanket. 
9. Upon completion of the 1-month treatment period, the guardians will complete the 
FNSC (Pliner, 1994). The principal investigator will collect the FNSC, new food log, 
and S-Anxiety scale of the STAIC at this time either through HIPAA protected email or 
in-person (Spielberger, 1973).  
10. Once the study is completed the guardians will be gifted the weighted blanket to use as 
they deem appropriate 
6.0 Sources of Research Material 
Data for this study will be gathered by caregiver report via the Food Neophobia Scale for 
Children (FNSC) questionnaire consisting of 10 questions and parent interview to gather 
information about the age and weight of the child (Pliner, 1994). Participants will complete the  
State-Trait Anxiety Inventory for Children (STAIC) S-Anxiety scale consisting of 20 questions 
(Spielberger, 1973). The guardians will also complete a food log. All data collected from the 
assessments will be used for research purposes. No data from records will be reviewed for this 
study. In addition, any protocol deviations or unanticipated problems will be monitored.  

6.0 Study Product Description 
A weighted blanket 10% or less of the participant’s body weight will be used under parent 
or therapist supervision as a calming strategy prior to introduction to new food paired with a 
preferred stationary task such as watching a video or reading a book.   
Weighted blankets are commercially available for children in weights of ten pounds, 
seven pounds, five pounds, and three pounds through the company yescool (yescool, n.d.). The 
blankets are made from glass beads and breathable polyester microfiber fabric according to the 
Amazon website. The glass beads are enclosed in five inch by 5 inch square compartments and 
stitched by high-density 15000 stitches to secure the glass beads within the blanket. Each 
participant will receive a weighted blanket that is approximately 10% of their body weight but 
does not exceed 10% of their body weight. For example, if a child weighs 55 pounds, they will 
receive a five-pound weighted blanket.  
7.0 Potential Risks 
Risks for this program are limited, but some potential risks are possible. 
- Loss of confidentiality. 
- Risk of mild to moderate discomfort due to having to reflect upon things that may make them 
feel uncomfortable such as anxiety level and food 
- Risk of discomfort using the weighted blanket 
8.0 Subject Safety 
This study controls for risk as all use of weighted blanket will be under adult supervision 
and not during sleep. In addition, the participant can refuse the use of the weighted blanket at any 

time during the study limiting any psychological risk or adverse events. Any adverse events will 
be reported immediately. 
Prior to the start of the study, researcher will discuss best practices for weighted blanket 
use and guardians will be provided with a handout detailing the protocol and safety guidelines. 
The guardian will have the blanket in their possession and will only offer the blanket during 
times detailed in the protocol. All subjects will be given the opportunity to exit the program and 
withdraw consent at any time if they determine that they are no longer able to participate. The 
researcher will be available via HIPAA compliant email throughout the study to answer any 
questions that may arise and offer support. In person meetings will also be available upon 
request. All data collected throughout the program will be maintained on password protected 
emails and computers to reduce the risk for breach of privacy. 
Dr. Claudia Hilton will provide supervision as the faculty sponsor through a weekly 
check-in via email, phone or zoom meeting with the principal investigator. The principal 
investigator will notify the faculty sponsor immediately via email with any questions or 
concerns. The principal investigator will include the faculty sponsor on any emails with the 
participants to ensure appropriate monitoring. All information pertaining to this study will be 
available to Dr. Hilton.  
9.0 Data Monitoring and Participant Confidentiality 
Data from questionnaires and food logs will be kept on password protected computers to 
ensure protection of participants confidentiality. No discussion of participants' information will 
be discussed in public settings and all data analysis will be performed in private settings. 

10.0 Potential Benefits 
By participating in this program, participants are expected to gain a better understanding 
of their own anxiety related to food and if a weighted blanket is beneficial to help them feel 
calmer and more regulated. The program aims to improve the everyday living experience of 
participants as it relates to mealtime. Participants will be provided with a weighted blanket for 
continued use as needed.  
11.0 Study Withdrawal/Discontinuation 
Possible reasons for withdrawal from this study: 
1. Time commitment 
2. Participant no longer wants to use the weighted blanket 
3. Use of weighted blanket becomes contraindicated 
4. Discontinuation from occupational therapy services 
Handling withdrawals: 
Withdrawal from the study will be accepted and an interview regarding reasons for withdrawal 
will be completed.  
Termination of this study will occur if there are no participants willing and able to participate.  
12.0 Biostatics and Subsidies 
A statistical analysis using IBM SPSS Statistics (Version 28) predictive analytics 
software will be completed. The STAIC S-Anxiety scale mean score during the treatment period 
will be compared to the control period mean score using paired-samples t-tests (Spielberger, 

1973). The control period mean score will be compared to the baseline. Similarly, the raw score 
from the FNSC during the treatment period and the raw control period score will be compared 
using paired-samples t-tests to understand if the children demonstrated a statistically significant 
change in food neophobia (Pliner, 1994). The control period raw score will be compared to 
baseline raw score using paired-samples t-tests. Nonparametric analysis will be used as 
necessary.  
The average number of foods tried during the control period will be compared to baseline 
and the average number of new foods tried during the control period will be compared to the 
average number of new foods tried in the  treatment period to understand if more foods were 
tried when using the weighted blanket. A paired-sample t-test will be completed to compare the 
control period to the treatment period. Nonparametric analysis will be used as necessary. 
      A weighted blanket will be provided to each of the participants of this study for their use 
following the study at no cost to the participant. The weighted blankets will be purchased by the 
principal investigator. This study is not funded by grants or subsidies. 
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