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Completed

NCT Number: NCT03427372

The Effect of Psychological State on Post Spinal Puncture Headache and Backache

To investigate the effect of patient mood before spinal anesthesia on post spinal puncture headache and backache

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ahi evran university education and research hospital

Kırşehir, Turkey (Türkiye)

About this study

Before spinal anesthesia patients' anxiety and depression mood will recorded with Beck anxiety and Beck depression scale fifteen minute before spinal anesthesia.Seven days after surgery post spinal puncture headache and backache will assess by a telephonic interview

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patient scehedule surgery under spinal anesthesia
  • between 18-80 years old

Exclusion criteria

  • patients with psychiatric disorders

Treatment and study plan

anxiety scale, depression scale

Behavioral

post spinal puncture headache and backache will be assess by using visual analogue scale, anxiety will assess by beck anxiety scale, depression mood will assess by beck depression scale

Primary outcomes

  1. post spinal puncture headache (PDPH)

    Time frame: one week after surgery

    For assessing PDPH, patients will ask whether they experienced headache through the use of a dichotomous scale (yes or no answer). The severity of PDPH will be assessed by the Dittmann's scale. This PDPH specific scale was composed of 4 levels of severity. Level 1 indicated minimal PDPH with no use of medications to manage PDPH with the patient able to participate in daily living activities without any inferences. Level 2 indicated mild PDPH that required the use of analgesics with patients still able to engage in daily living activities. Level 3 indicated moderate PDPH where analgesic administration was required to control the level of pain. Level 4 indicated severe PDPH with an epidural blood patch recommended.

Secondary outcomes

  1. anxiety

    Time frame: fifteen minutes before spinal anesthesia

    Anxiety will evaluated by the Beck Anxiety Inventory (BAI), which consists of 21 questions about how the individual has felt in the preceding week regarding common anxiety symptoms, such as sweating, tremor, fear, and feelings of distress. The cutoff point for anxiety is 12, and scores between 1 and 11 are considered subsyndromal anxiety.

  2. depression

    Time frame: fifteen minutes before spinal anesthesia

    Depression will assess by beck depression scale. The Beck Depression Scale (BDS) uses a 3-point Likert type response scale to 21 questions. In the scale, a total of 0-13 points are considered 'normal', 14-25 points to indicate 'depression', and 26-63 points to indicate'severe depression'.

  3. post spinal puncture backache (PDPB)

    Time frame: one week after surgery

    The presence of backache will asses by using visual analogue scale (VAS). Patients will familiarized with 10 cm marked VAS for assessment of back pain, where 0 cm defines no pain, and 10 cm defines the maximum intolerable pain

Sponsors and collaborators

Lead sponsor

Ahi Evran University Education and Research Hospital

Other

Registry information

Official study title

The Effect of Anxiety and Depression Mood on Post Spinal Puncture Headache and Backache

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 9, 2018
Registry last updated
Oct 2, 2019

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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