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NCT Number: NCT07828028

The Effect of the 4-7-8 Breathing Technique on Anxiety, Symptom Burden, and Sleep Quality During Chemotherapy

This study aims to determine the effects of the 4-7-8 breathing technique on anxiety, symptom severity, and sleep quality during treatment. A randomized controlled trial design was employed, involving 64 participants (intervention group: n=32; control group: n=32) undergoing their third treatment cycle. The intervention group received the 4-7-8 breathing technique twice daily for 21 days in addition to routine care, while the control group received routine care and standard supportive care. Data will be collected at pre-test and post-test stages using the Descriptive Information Form, the State-Trait Anxiety Inventory (STAI-State), the Edmonton Symptom Assessment System (ESAS), and the Pittsburgh Sleep Quality Index (PSQI). Data analysis will be performed using the SPSS 22.0 software.

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Key information

Conditions

Chemotherapy Anxiety Disorders Dyssomnias Mental Disorders Neoplasms Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gaziantep City Hospital

Gaziantep, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Requirements include being 18 years of age or older;
  • not being in the third stage of the disease;
  • having no communication barriers, mental or physical impairments, or visual or hearing impairments;
  • being able to speak Turkish and agreeing to participate.

Exclusion criteria

  • Those who do not agree to participate in the study,
  • Those under the age of 18

Treatment and study plan

4-7-8 Breathing Technique

Behavioral

Participants in the intervention group will receive routine chemotherapy care in addition to the 4-7-8 breathing technique. The technique will be taught individually by the researcher face-to-face before chemotherapy. Participants will perform the technique twice daily, once in the morning and once in the evening, for 21 consecutive days. Each session will consist of four cycles of the 4-7-8 breathing technique.

Routine care

Other

Participants in the control group will receive routine nursing care and standard chemotherapy care according to the usual clinical practice. No 4-7-8 breathing technique will be provided during the study period.

Primary outcomes

  1. State Anxiety Level

    Time frame: Baseline and Day 21

    State anxiety level was assessed using the State-Trait Anxiety Inventory-State subscale (STAI-S). The STAI-S consists of 20 items, with total scores ranging from 20 to 80. Higher scores indicate higher levels of state anxiety. State anxiety was assessed at baseline and on Day 21.

  2. Sleep Quality

    Time frame: Baseline and Day 21

    Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI). The PSQI evaluates subjective sleep quality and sleep disturbances, with higher total scores indicating poorer sleep quality. Sleep quality was assessed at baseline and on Day 21.

  3. Chemotherapy Symptom Burden

    Time frame: Baseline and Day 21

    Chemotherapy symptom burden was assessed using the Edmonton Symptom Assessment System (ESAS). The severity of symptoms was rated on a 0-10 numerical scale, with higher scores indicating greater symptom severity. Chemotherapy symptom burden was assessed at baseline and on Day 21.

Sponsors and collaborators

Lead sponsor

Malatya Turgut Ozal University

Other

Registry information

Official study title

The Effect of the 4-7-8 Breathing Technique Applied During Chemotherapy on Anxiety, Symptom Burden, and Sleep Quality

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 18, 2026
Registry last updated
Sep 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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