To study the effect of sleep hygiene (which would include changes in habits , lifestyle ,environmental changes and occupation) by using a framework called person environment occupation framework - it is a pilot study.
- Conditions
- Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx
- Registration Number
- CTRI/2022/04/041889
- Lead Sponsor
- Tata Memorial Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Patients post treatment completion [Surgery (on discharge day) or Radiation(last day of radiation or Chemotherapy (last cycle of chemotherapy)].
2. Patients having moderate to severe insomnia- as assessed using Insomnia Severity Index (ISI â?? Last month) having score between 14-28.
3. Both male and female
4. Patients who can read, write and comprehend Hindi or English.
5. Patients and caregiver who are ready to follow up for eight weeks telephonically (audio call and or WhatsApp video call).
1. Patient with metastatic cancer.
2. Patient with other cancers.
3. Palliative care patients.
4. Patients and the caregiver who are unable to follow up telephonically.
5. Patients reporting pain more than 3 on numeric pain rating scale during follow -up will be excluded.
6. Patients with psychological disorders.
7. Patients with cognitive impairments.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Objective: <br/ ><br>1. To assess the effectiveness of sleep hygiene on quality of sleep using Pittsburgh Sleep Quality Index Scale (PSQI) in head and neck cancer patients with insomnia.Timepoint: 8 weeks after enrollment
- Secondary Outcome Measures
Name Time Method 1. To assess the effect of sleep hygiene on quality of life using Functional Assessment of Cancer Therapy (FACT-HN)in head and neck cancer patients.Timepoint: 8 weeks after enrollment;2. To assess the compliance of the patient for the sleep hygiene intervention by the use of sleep diary.Timepoint: 8 weeks after enrollment