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

NCT07828028 | Completed

• 1 other identifier: E-30785963-020-306357
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chemotherapy

Keywords

4-7-8 breathing technique; chemotherapy; symptom burden; sleep quality; anxiety; cancer; oncology nursing

Outcome Measures

Primary Outcomes (3)

• State Anxiety Level

  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.

  Baseline and Day 21

• Sleep Quality

  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.

  Baseline and Day 21

• Chemotherapy Symptom Burden

  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.

  Baseline and Day 21

Study Arms (2)

4-7-8 Breathing Technique

EXPERIMENTAL

Participants receiving the 3rd cycle of chemotherapy will be assigned to the intervention group. Participants will receive routine nursing care and standard chemotherapy care in addition to the 4-7-8 breathing technique. The breathing technique will be individually taught face-to-face by the researcher before chemotherapy. Participants will perform the technique twice daily, in the morning and evening, for 21 consecutive days. Each session will consist of four cycles of the 4-7-8 breathing technique. Assessments will be performed at baseline and on the 21st day to evaluate anxiety, chemotherapy symptom burden, and sleep quality.

Behavioral: 4-7-8 breathing technique; Other: routine care

Routine Care

ACTIVE COMPARATOR

Participants receiving the 3rd cycle of chemotherapy will be assigned to the control group. Participants will receive routine nursing care and standard chemotherapy care according to usual clinical practice. The 4-7-8 breathing technique will not be provided during the 21-day study period. Assessments will be performed at baseline and on the 21st day to evaluate anxiety, chemotherapy symptom burden, and sleep quality.

Other: routine care

Interventions

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.

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.

4-7-8 Breathing Technique; Routine Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Malatya Turgut Ozal University: lead

Study Sites (1)

Gaziantep City Hospital

Gaziantep, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Anxiety Disorders; Neoplasms

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 18, 2026
• Study Start: March 15, 2025
• Primary Completion: June 25, 2026
• Study Completion: June 25, 2026
• Last Updated: September 23, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)