- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07797608
Effect of Progressive Muscle Relaxation on Parental Anxiety (PMR-PA)
7. september 2026 opdateret af: Duygu ALTUNTAŞ, Akdeniz University
The Effect of Progressive Muscle Relaxation Exercises on Anxiety Among Parents of Children With Cancer: A Randomized Controlled Trial
This randomized controlled trial aims to evaluate the effect of progressive muscle relaxation exercises on anxiety levels among parents who are the primary caregivers of children diagnosed with cancer and receiving inpatient treatment.
A total of 112 parents will be randomly assigned to either the intervention or control group.
Parents in the intervention group will participate in researcher-led progressive muscle relaxation sessions.
Anxiety will be assessed using the State Anxiety Inventory (STAI-I).
The study will be conducted at the Pediatric Hematology-Oncology Clinic of Akdeniz University Hospital in Antalya, Türkiye.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Parents of children diagnosed with cancer may experience substantial anxiety throughout their child's diagnosis and treatment.
Progressive muscle relaxation is a nonpharmacological technique involving the systematic tensing and relaxing of major muscle groups combined with deep breathing.
Eligible parents will be randomly allocated in equal numbers to the intervention or control group using a computer-generated randomization sequence.
The intervention will be delivered individually in a private clinical education room.
Participants will progressively tense and relax the muscles of the face, neck, shoulders, chest, abdomen, legs, and feet.
Each muscle group will be tensed for 5 seconds and relaxed for 10 seconds while participants practice deep breathing and visualize a wave of relaxation throughout the body.
Anxiety will be assessed using the State Anxiety Inventory (STAI-I), and changes in anxiety scores will be compared between the groups.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
112
Fase
- Ikke anvendelig
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Beskrivelse
Inclusion Criteria:
- Being the parent and primary caregiver of a child diagnosed with cancer
- The child having been diagnosed with cancer within the previous 12 months
- The child currently receiving inpatient treatment in the study clinic
- Being able to communicate without hearing or speech-related barriers
- Being able to understand and answer the study questions
- Providing written informed consent
Exclusion Criteria:
- Not meeting any of the inclusion criteria
- Withdrawing consent at any time
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Progressive Muscle Relaxation
Participants will receive two individual progressive muscle relaxation sessions in a private clinical education room over two weeks.
Each session will last approximately 15 minutes and will be conducted once weekly.
|
Participants will receive routine clinical care and will not participate in progressive muscle relaxation sessions during the study period.
|
|
Ingen indgriben: Control
Participants in the control group will receive routine care provided by the clinic and will not participate in progressive muscle relaxation sessions during the study period.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in State Anxiety
Tidsramme: 2 weeks
|
State anxiety will be measured using the State Anxiety subscale of the State-Trait Anxiety Inventory (STAI-S).
The subscale contains 20 items and yields a total score ranging from 20 to 80. Higher scores indicate higher state anxiety.
|
2 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Duygu Altuntaş, PhD, Akdeniz University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
15. august 2026
Primær færdiggørelse (Anslået)
20. juli 2027
Studieafslutning (Anslået)
20. juli 2027
Datoer for studieregistrering
Først indsendt
10. august 2026
Først indsendt, der opfyldte QC-kriterier
31. august 2026
Først opslået (Faktiske)
1. september 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
9. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- TBAEK-976
Plan for individuelle deltagerdata (IPD)
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