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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.

Effectiveness of sleep hygiene using person environment occupation framework in head and neck cancer patients-a pilot study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/04/041889
Enrollment
34
Registered
2022-04-18
Start date
Unknown
Completion date
Unknown
Last updated
2022-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx

Interventions

Intervention1: Sleep hygiene: Sleep hygiene using person environment occupation framework. Control Intervention1: NIL: NIL

Sponsors

Tata Memorial Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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).

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Primary Objective: 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

MeasureTime frame
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—

Countries

India

Contacts

Public ContactDr Varsha Davane

Tata Memorial Hospital

vagalmanjusha@yahoo.com9867552266

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026